sanders dr clinical trial of the implantable contact lens for moderate to high myopia

7/29/2019 Sanders DR Clinical Trial of the Implantable Contact Lens for Moderate to High Myopia

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Sanders DR, Vukich JA, Doney K, Gaston M; Implantable Contact Lens in Treatment of Myopia Study

Group. U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for

moderate to high myopia. Ophthalmology. 2003 Feb;110(2):255-66.

Lens sizing and power calculation

Sizing of myopic lenses (11.513.0 mm) was determined by the horizontal white-to-white measurement and the

ACD measurement. For eyes with ACD measurements of 2.8 mm to 3.5 mm, the lens size was calculated by

adding 0.5 mm to the horizontal white-to-white measurement. Eyes exhibiting an ACD greater than 3.5 mm

required the addition of up to 1.0 mm to the white-to-white measurement, up to a maximum length of 13.0 mm.

Patients with an ACD less than 2.8 mm were excluded from the study. Calculated lens sizes between the

available lens diameters (in 0.5-mm steps) were generally rounded down if the ACD was 3.5 and rounded up if

the ACD was >3.5 mm. White-to-white measurements were obtained using calipers at a slit lamp or using the

Orbscan unit. All lens power calculations were performed by STAAR Surgical Co using a modified vertex

formula.


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U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia

The Implantable Contact Lens in Treatment of Myopia (ITM) Study Group *,

Received 25 October 2001

Accepted 2 August 2002

Available online 5 February 2003

http://dx.doi.org/10.1016/S0161-6420(02)01771-2, How to Cite or Link Using DOI

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Abstract

Purpose

To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate to high myopia.

Design

Prospective nonrandomized clinical trial.

Participants

Five hundred twenty-three eyes of 291 patients with between 3 and 20.0 diopters (D) of myopia participating

in the U. S. Food and Drug Administration clinical trial of the ICL for myopia.

InterventionImplantation of the ICL.

Main outcome measures

Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events,

operative and postoperative complications, lens opacity analysis (Lens Opacity Classification System III),

subjective satisfaction, and symptoms.

Results

Twelve months postoperatively, 60.1% of patients had a visual acuity of 20/20 or better, and 92.5% had an

uncorrected visual acuity of 20/40 or better. Patients averaged a 10.31-line improvement in UCVA, 61.6% of

patients were within 0.5 D, and 84.7% were within 1.0 D of predicted refraction. Only one case (0.2%) lost > 2

lines of BSCVA. Gains of 2 or more lines of BSCVA occurred in 55 cases (11.8%) at 6 months and 41 cases (9.6%)

at 1 year after ICL surgery. Early and largely asymptomatic, presumably surgically induced anterior subcapsular(AS) opacities were seen in 11 cases (2.1%); an additional early AS opacity (0.2%) was seen because of

inadvertent anterior chamber irrigation of preservative-containing solution at surgery. Two (0.4%) late ( 1 year

postoperatively) AS opacities were observed. Two (0.4%) ICL removals with cataract extraction and intraocular

lens implantation have been performed. Patient satisfaction (very/extremely satisfied) was reported by 92.4%

of subjects on the subjective questionnaire; only four patients (1.0%) reported dissatisfaction. Slightly more

patients reported an improvement at 1 year over baseline values for the following subjective symptoms:

quality of vision, glare, double vision, and night driving difficulties. Only a 3% difference between pre-ICL and

post-ICL surgery was reported for haloes.

Conclusions

The results support the safety, efficacy, and predictability of ICL implantation to treat moderate to high

myopia.

Currently, the two most popular procedures for the correction of myopia are photorefractive keratectomy

(PRK) and laser in situ keratomileusis (LASIK). Studies on PRK have shown it to effectively correct up to 6.00

diopters (D) of myopia.1 and 2 However, studies have also shown that it is less effective and predictable on

moderate or high myopia (6.00 D).3 and 4 Complications from PRK on eyes with high myopia include corneal

scarring, loss of best spectacle-corrected visual acuity (BSCVA), and regression.5

In recent years, LASIK has emerged as the refractive corneal surgical procedure of choice for the correction of

low myopia between 1.00 D and 6.00 D. Despite the widespread acceptance of LASIK within the ophthalmic

community, this moderately invasive technique that directly affects the clear, central, optical zone is associated
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#item1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#item1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#item1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#FN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#COR1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#COR1http://offcampus.tums.ac.ir:2196/10.1016/S0161-6420(02)01771-2http://offcampus.tums.ac.ir:2058/science/help/doi.htmhttp://offcampus.tums.ac.ir:2058/science?_ob=RedirectURL&_method=outwardLink&_partnerName=936&_eid=1-s2.0-S0161642002017712&_pii=S0161642002017712&_origin=article&_zone=art_page&_targetURL=https%3A%2F%2Fs100.copyright.com%2FAppDispatchServlet%3FpublisherName%3DELS%26contentID%3DS0161642002017712%26orderBeanReset%3Dtrue&_acct=C000052611&_version=1&_userid=1403562&md5=c9e14d46c09f5ae6e93eae6cfe8a9bb3http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB2http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB3http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB4http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB5http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB5http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB4http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB3http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB2http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB1http://offcampus.tums.ac.ir:2058/science?_ob=RedirectURL&_method=outwardLink&_partnerName=936&_eid=1-s2.0-S0161642002017712&_pii=S0161642002017712&_origin=article&_zone=art_page&_targetURL=https%3A%2F%2Fs100.copyright.com%2FAppDispatchServlet%3FpublisherName%3DELS%26contentID%3DS0161642002017712%26orderBeanReset%3Dtrue&_acct=C000052611&_version=1&_userid=1403562&md5=c9e14d46c09f5ae6e93eae6cfe8a9bb3http://offcampus.tums.ac.ir:2058/science/help/doi.htmhttp://offcampus.tums.ac.ir:2196/10.1016/S0161-6420(02)01771-2http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#COR1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#COR1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#FN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#item1


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with a sizable number of potential intraoperative and postoperative complications; the incidence has been

found to increase with higher refractive errors.

In this moderate to high myopia population (>6.00 D), an in- sufficient layer of untouched stromal base tissue

can quickly lead to ectasia, which has been reported to significantly increase glare.6 and 7 Additional

complications include edema, pain, photophobia, flap/microkeratome complications including corneal

penetration,8 unstable refraction, loss of BSCVA, significant irregular astigmatism, corneal ectasia,9, 10, 11, 12,

13 and 14 and diffuse lamellar keratitis, also known asSands of Sahara Syndrome.15 Furthermore, LASIK

enhancements are commonplace, exposing the patient to these intraoperative risks on multiple occasions.

Despite these complications, LASIK is performed widely and seems to be a good procedure for myopia of


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Patients were examined at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after ICL

implantation. Monitoring systems were implemented at the onset of the study to ensure that a high level of

follow-up was achieved through the prospective 2-year study end point.

The main outcome measures were uncorrected visual acuity (UCVA), refraction, BSCVA, adverse events,

operative and postoperative complications, lens opacity analysis (Lens Opacity Classification System III [LOCS

III]), and subjective satisfaction and symptoms.

Clarity of the crystalline lens was evaluated using LOCS III.31 This standardized photographic grading system,

generally used to assess the development of cataracts, classifies lens characteristics into four major categories:

nuclear color, nuclear opalescence, cortical appearance, and posterior subcapsular appearance. Anterior

subcapsular (AS) appearance used the same classification photographs as the posterior subcapsular region, but

the slit lamp was used to further localize the opacity.

A standardized subjective, self-administered questionnaire was used at all investigational sites at the

preoperative and 12-month postoperative visits to obtain patients feedback regarding their satisfaction with

the results of the ICL surgery, their quality of vision, and to report on changes in patient symptoms after ICL

implantation compared with baseline.

ICL for myopia

ICL device

The subject of this study is a posterior chamber phakic IOL termed by its manufacturer the Implantable Contact

Lens (STAAR Surgical Co., Monrovia, CA). The ICL is designed to vault anteriorly to the crystalline lens and isintended to have minimal contact with the natural lens. The lens is made from a new generation of

biocompatible IOL materials termed Collamer. Collamer is composed of a proprietary, hydrophilic porcine

collagen (3.5 mm. White-to-white measurements were obtained using calipers at a slit lamp or using the

Orbscan unit. All lens power calculations were performed by STAAR Surgical Co using a modified vertex

formula.

Surgical procedure

Within 7 days of surgery, patients received two peripheral iridectomies performed 90 apart with a

neodymium:yttriumaluminumgarnet or argonkrypton laser, generally at the 10:30 and 1:30 positions. The

day of surgery, patients were administered dilating and cycloplegic agents, after which an anesthetic of the

surgeons choice was applied to the operative eye. A Model V4 ICL was inserted through a small, 3-mm, clear

corneal incision. The lens was then injected through the incision into the anterior chamber (Staar MicroSTAAR

injector, STAAR Surgical Co., Monrovia, CA) and allowed to slowly unfold. Distal and then proximal footplates

were tucked under the iris with a modified intraocular spatula. Correct positioning of the ICL in the center of

the pupillary zone was verified before intraocular miotic was used to decrease pupil size. Any remaining

viscoelastic was scrupulously irrigated out of the anterior chamber with balanced salt solution.

Postoperative management

Patients were administered 1 drop of Ocuflox (ofloxacin solution, 0.3%, Allergan Inc., Irvine, CA) and prescribed

TobraDex (tobramycin and dexamethasone suspension; Alcon Laboratories, Ft. Worth, TX) four times daily for a

total of 16 days, beginning with 1 drop four times daily for the first 4 postoperative days and steadily reducing

the dosage by 1 drop every 4 days thereafter.
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB31http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB31


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Statistical issues/data management

Statistical analyses were performed using SPSS 10.0 (SPSS Inc., Chicago, IL). Data were compiled from the

prospective, standardized case report forms and subjective patient questionnaires (in Access and Visual Basic

databases) provided in the Investigational Device Exemption clinical study protocol. A sample size of 300 study

subjects was selected because it provides a one-sided upper 95% confidence limit of 20 D,

cylinder >2.5 D, age >45 years) were also implanted but are not reported as part of this cohort. Their exclusion

did not significantly change the results or conclusions drawn from this study.

One hundred seventy-six of the 291 subjects treated were female (60.5%). Most of the Myopia ICL PMA Cohort

subjects (84.5%) were white. The mean age standard deviation at the time of the implantation of the STAAR

Myopia ICL (primary eye surgery in bilateral subjects) was 36.5 5.9 years, with a range of 22 to 45 years.

Fifty-two (47 patients) of the 523 eyes (9.9%) in the myopia ICL clinical study were reported with preexistingocular conditions. The most prevalent conditions included 18 eyes with myopic retinal degeneration, 20 eyes

with amblyopia, and 9 eyes with early cataract; the latter were all visually insignificant. Twelve eyes had a

history of prior ocular surgery in the study eye: astigmatic keratotomy (seven eyes), photocoagulation for

retinal tears (three eyes), and muscle surgery (two eyes).

The % Accountability was defined asEyes Available for Analysis divided by (number of eyes enrolled

minusdiscontinued eyesminuseyes not yet eligible for time interval), in accordance with FDA

Guidance Document for Refractive Lasers (Checklist for Information Usually Submitted in an Investigational

Device Exemption (IDE)Application for Refractive Surgery Lasers September 5, 1997). In the Myopia ICL

clinical study postoperative follow-up ranged between 90.1% and 100% for all postoperative visits through 24

months (Table 1). The decreasing numbers of patients available for analysis with time reflect the ongoing

nature of the clinical trial.Table 1. AccountabilityImplantable Contact Lens Study Cohort Eyes

1

Day

1

Week

1

Month

3

Months

6

Months

12

Months

24

Months

Available for analysis (number of eyes) 523 501 505 482 468 428 258

% Accountability = eyes available for analysis

divided by (enrolledminus

discontinuedminusnot yet eligible for

time interval)

100% 96.2% 97.3% 92.9% 91.4% 90.1% 94.5%

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UCVA

Preoperatively, in the cohort of cases with good visual potential (BSCVA 20/20 or better at baseline), no eyes

(0%) were 20/80 or better, with only two eyes (0.6%) 20/200 or better uncorrected at baseline (Table 2). At 6

months UCVA improved to 20/20 or better in 55.8% of patients and at one year it improved in 60.1% of

patients after implantation of the ICL. The proportion of eyes with 20/40 or better UCVA at 6 and 12 months,

respectively, was 92.1% and 92.5%. Furthermore, at the 2-year visit, 93.3% of eyes had improved to 20/40 or

better.
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Figure 1. Uncorrected visual acuity over time in the cohort of cases with best spectacle-corrected visual acuity

of 20/20 or better preoperatively.

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Refractive outcomes

MRSE

Preoperative MRSE for this study cohort ranged from 3.00 to 20.00 D of myopia (mean, 10.046 D). Only

21.2% of eyes had a preoperative myopia 7.0 D. At baseline, no eyes (0%) fell within 1.0 D (MRSE)

compared with 86.1% at 12 months after ICL implantation (Table 3).

Table 3. Manifest Refraction Spherical Equivalent with Time in Patients with an Implantable Contact Lens for

Moderate to High Myopia

SphericalEquivalen

t

Preoperative 1 Week 1 Month 3 Months 6 Months 12 Months 24 Months

n % n % n % n % n % n % n %

+1.01 D 0 (0.0%) 3 (0.6%) 4 (0.8%) 5 (1.0%) 4 (0.9%) 1 (0.2%) 2 (0.8%)

+1.00 to

+0.01 D0 (0.0%) 79 (16.0%) 101 (20.2%) 108 (22.5%) 94 (20.3%) 76 (17.9%) 32 (12.4%)

0.00 to

1.00 D0 (0.0%) 336 (67.9%) 332 (66.3%) 313 (65.2%) 300 (64.7%) 289 (68.2%) 183 (70.9%)

1.01 to

2.00 D0 (0.0%) 53 (10.7%) 39 (7.8%) 31 (6.5%) 43 (9.3%) 32 (7.5%) 23 (8.9%)

2.01 to7.00 D

111 (21.2%) 22 (4.4%) 22 (4.4%) 20 (4.2%) 20 (4.3%) 24 (5.7%) 18 (7.0%)

7.01 to

10.00 D175 (33.5%) 2 (0.4%) 3 (0.6%) 3 (0.6%) 3 (0.6%) 2 (0.5%) 0 (0.0%)

10.01 to

15.00 D185 (35.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)

15.01 to

20.00 D52 (9.9%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)

>20.00 D 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#FIG1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://services.elsevier.com/SDWebExport/export/figure/S0161642002017712/1-s2.0-S0161642002017712-gr1.sml/ppthttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE3http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE3http://services.elsevier.com/SDWebExport/export/figure/S0161642002017712/1-s2.0-S0161642002017712-gr1.sml/ppthttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#FIG1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#gr1


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Spherical

Equivalen

t

Preoperative 1 Week 1 Month 3 Months 6 Months 12 Months 24 Months

n % n % n % n % n % n % n %

Total 523(100.0%

)495

(100.0%

)501

(100.0%

)480

(100.0%

)464

(100.0%

)424

(100.0%

)258

(100.0%

)

Mean 10.046 0.526 0.448 0.380 0.436 0.496 0.564

SD 3.748 0.950 0.994 1.019 1.061 0.984 0.980

Range20.00 to

3.00

7.88 to

1.25

8.13 to

1.50

8.25 to

3.50

9.63 to

1.38

8.00 to

1.13

5.25 to

1.13

D = diopters; SD = standard deviation.

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Predictability of manifest refraction (attempted versus achieved)

An ICL power calculation formula based on geometric optics was developed by the study sponsor. Myopic

lenses were available from 3.0 D to 20.0 D. Some of the study eyes (9.9%) had more than 15 D of myopia

preoperatively, which could not be fully corrected by the strongest available ICL power. These particular caseswere targeted to be undercorrected.

Table 4presents the predictability of manifest refraction outcomes associated with implantation of the ICL for

the correction of myopia for all eyes in the study cohort. Comparable to uncorrected visual acuity results,

predictability was achieved immediately in the first postoperative week and maintained over the duration of

the postoperative follow-up period, with 55.8% of eyes within 0.50 D and 80.6% within 1.0 D at the 1-

week visit. At 6 months postoperatively, 60.3% of eyes were within 0.50 D of their attempted correction;

61.6% were within 0.50 D at 12 months. The percentage of eyes within 1.0 D at 6 months was 86.6% and

84.7% at the 12-month follow-up window.

Table 4. Predictability of Manifest Refraction Attempted vs. Achieved in Patients with an Implantable Contact

Lens for Moderate to High Myopia

1 Week n/N(%)

1 Month n/N(%)

3 Monthsn/N (%)

6 Monthsn/N (%)

12 Monthsn/N (%)

24 Monthsn/N (%)

0.50 D276/495

(55.8%)

301/501

(60.1%)

301/480

(62.7%)

280/464

(60.3%)

261/424

(61.6%)

148/258

(57.4%)

1.00 D399/495

(80.6%)

420/501

(83.8%)

421/480

(87.7%)

402/464

(86.6%)

359/424

(84.7%)

207/258

(80.2%)

2.00 D472/495

(95.4%)

480/501

(95.8%)

462/489

(96.3%)

443/464

(95.5%)

410/424

(96.7%)

247/258

(95.7%)

Overcorrected

>+19/495 (1.8%)

10/501

(2.0%)7/480 (1.5%) 7/464 (1.5%) 4/424 (0.9%) 6/258 (2.3%)

Overcorrected

>+24/495 (0.8%) 1/501 (0.2%) 1/480 (0.2%) 0/464 (0.0%) 0/424 (0.0%) 0/258 (0.0%)

Undercorrected


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Change in BSCVA

BSCVA was well preserved after ICL implantation, with only one eye (0.2%) losing more than 2 lines of BSCVA

between 1 and 24 months postoperatively (Table 6). This 42-year-old female with 12.75 D myopia

inadvertently received a carbachol solution containing preservative irrigated intracamerally at the end of ICL

surgery instead of the intended preservative-free carbachol. She had transient corneal edema, which

subsequently cleared, and vacuoles were noted in the AS region 2 months

postoperatively. At 6 months postoperatively, her BSCVA was 20/20 (compared with 20/20 preoperatively), but

an AS cataract was present. Between 1 and 2 years postoperatively, her BSCVA decreased to 20/40 because of

cataract. At 26 months postoperatively, an ICL removal cataract extraction with IOL implantation was

performed with a final postoperative BSCVA of 20/20.

Table 6. Change in Best Spectacle-corrected Visual Acuity in Patients with an Implantable Contact Lens for

Moderate to High Myopia

1 Week n/N

(%)

1 Month n/N

(%)

3 Months n/N

(%)

6 Months n/N

(%)

12 Months n/N

(%)

24 Months n/N

(%)

Decrease >2

lines 3/498 (0.6%) 0/501 (0.0%) 0/481 (0.0%) 0/464 (0.0%) 0/427 (0.0%) 1/257 (0.4%)

Decrease 2

lines6/498 (1.2%) 3/501 (0.6%) 1/481 (0.2%) 2/464 (0.4%) 3/427 (0.7%) 3/257 (1.2%)

Decrease 1

line

56/498

(11.2%)

33/501

(6.6%)18/481 (3.7%) 19/464 (4.1%) 23/427 (5.4%) 20/257 (7.8%)

No change252/498

(50.6%)

248/501

(49.5%)

221/481

(45.9%)

218/464

(47.0%)

189/427

(44.3%)

106/257

(41.2%)

Increase 1 line137/498

(27.5%)

163/501

(32.5%)

189/481

(39.3%)

170/464

(36.6%)

171/427

(40.0%)

99/257

(38.5%)

Increase 2

lines

30/498

(6.0%)

37/501

(7.4%)39/481 (8.1%) 41/464 (8.8%) 30/427 (7.0%) 19/257 (7.4%)

Increase >2

lines

14/498

(2.8%)

17/501

(3.4%)13/481 (2.7%) 14/464 (3.0%) 11/427 (2.6%) 9/257 (3.5%)

Mean change 0.33 0.50 0.60 0.59 0.56 0.53

Not reported 3 4 1 4 1 1

Total 501 505 482 468 428 258

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Only six cases (1.1%) lost exactly 2 lines of BSCVA 6 months or later. One had a surgically induced opacity (lens

touch at surgery because of removal and reinsertion of ICL) with a BSCVA of 20/25 (from 20/15); one had anearly AS opacity decreasing vision from a preoperative BSCVA of 20/30 (because of amblyopia) to 20/50; one of

these was due to a dry eye/irregular corneal surface; one case exhibited worsening myopic retinal

degeneration; and the last two cases were transient findings, with BSCVA improving to within 1 line of

preoperative values and both having a final BSCVA of 20/30 or better at the last visit.

It should be noted that BSCVA improved 2 lines in 30 (7.0%) eyes and more than 2 lines in an additional 11 eyes

(2.6%) at 12 months. The mean improvement in BSCVA ranged from 0.5 to 0.6 lines between 1 and 24 months

postoperatively.

Secondary surgeries/adverse events
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE6http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE6http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE6http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE6


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Secondary surgical interventions were reported in 12 eyes (2.3%) in the study cohort. Four (0.7%) cases were

repositioned; three within the first postoperative month and one at 11 months postoperatively. Two (0.4%)

ICLs were replaced, because they were too long (at 2 and 3 days postoperatively); two (0.4%) ICLs were

replaced because they were too short (at 3 weeks and 17 months postoperatively); one (0.2%) was replaced

because of incorrect power (at 9 months postoperatively); one (0.2%) ICL was replaced for a longer lens (at 26

months postoperatively), but this second ICL was subsequently removed 4 months later, with no crystalline

lens surgery required. In none of the preceding cases was there a loss of BSCVA.

Two (0.4%) cases underwent ICL removal, cataract extraction, and IOL implantation. One 18 D myopic

individual developed an AS opacity 12 months postoperatively. The second case was the patient described

previously who experienced a surgical mishap when miotic with preservative was irrigated into the anterior

chamber during surgery. No loss of BSCVA occurred after cataract extraction.

Complications

Surgical complications

Eleven (2.1%) of the cases required ICL removal and reinsertion during surgery or the same day as surgery.

These removals and subsequent reinsertions occurred as a result of the lens flipping (i.e., an ICL implanted

upside down must be removed and reinserted). Six of these resulted in early AS lens opacities; one of these

cases resulted in a 2-line loss of BSCVA. One additional case (0.2%) required repositioning during surgery.

Except for the one case described previously, none of these cases had a loss of BSCVA. No other significant

surgical complications occurred.Postoperative complications

Complications after implantation of the ICL for the correction of myopia were extremely rare (Table 7). Only

three (0.6%) complications were reported from 1 to 6 months after ICL implantation in the 523 study eyes; no

complications were reported after 6 months through 24 months. No iritis or corneal edema at the incision site

was observed after the first postoperative week. Postoperative complications included one retinal detachment

at 6 months, one failed attempt to correct a slight ovalization of the pupil with argon laser synechiolysis at 6

months, and one treatment of an acute retinal hole at 3 months postoperative. There was one iris prolapse

repair 1 day after surgery. None of the cases with postoperative complications lost BSCVA.

Table 7. Postoperative Complications in Patients with an Implantable Contact Lens for Moderate to High

Myopia

1 Day 1 Week 1 Month 3 Months 6 Months 12 Months 24 Months

n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)

Iritis101/52

3

(19.3%

)

6/50

1

(1.2%

)

0/50

5

(0.0%

)

0/48

2

(0.0%

)

0/46

8

(0.0%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

Corneal

edema59/523

(11.3%

)

2/50

1

(0.4%

)

0/50

5

(0.0%

)

0/48

2

(0.0%

)

0/46

8

(0.0%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

Retinal

detachment0/523 (0.0%)

0/50

1

(0.0%

)

0/50

5

(0.0%

)

0/48

2

(0.0%

)

1/46

8

(0.2%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

Iris prolapse

repair1/523 (0.2%)

0/50

1

(0.0%

)

0/50

5

(0.0%

)

0/48

2

(0.0%

)

0/46

8

(0.0%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

Treatmentof acute

retinal hole

0/523 (0.0%)0/50

1

(0.0%

)

0/50

5

(0.0%

)

1/48

2

(0.2%

)

0/46

8

(0.0%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

Attempted

argon laser

synechiolysi

s

0/523 (0.0%)0/50

1

(0.0%

)

0/50

5

(0.0%

)

0/48

2

(0.0%

)

1/46

8

(0.2%

)

0/42

8

(0.0%

)

0/25

8

(0.0%

)

n/N =

Full-size table
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE7http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE7


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Intraocular pressure

Twenty-one cases (4.0%) required secondary surgical intervention for management of acute pressure rises

within a month after surgery because of small iridectomies (performed before ICL insertion) that were clogged

with viscoelastic. Most of these secondary surgical interventions were additional yttriumaluminumgarnet

laser iridotomies to enlarge an existing iridotomy site (16 cases). Three cases involved irrigation of the anterior

chamber, and there were two surgical iridectomies. All pressures returned to normal after the secondary

procedures with no loss of BSCVA.

Only one case (0.2%) was reported with intraocular pressure (IOP) more than 25 mmHg at 6 months or later. At

12 months postoperatively, the patients IOP was 28 mmHg; however, it was less than 25 mmHg at five

subsequent visits. At 24 months postoperatively the IOP was 22 mmHg with the patient on no pressure-

lowering medication.

It should be noted that no patients in the study cohort required long-term glaucoma medication, and there was

no significant late elevation in IOP after implantation of the ICL for myopia.

LOCS III opacities

Table 8presents the distribution of LOCS III scores over time. Trace nuclear color remained relatively

unchanged with 22.0% at baseline, 23.1% at 6 months, and 24.2% at 12 months postoperatively. Theproportion of eyes with trace nuclear opalescence was also unchanged compared with baseline values (22.8%

preoperative; 22.3% at 12 months). There was a reduction in the trace cortical score from 5.0% at baseline to

1.9% at the 12-month follow-up visit. Furthermore, all eyes had no or trace posterior subcapsular changes at all

postoperative visits. AS opacities were seen with much greater frequency than in the other areas of the

crystalline lens.

Table 8. Distribution of Lens Opacity Classification System III Scores Over Time in Patients with an Implantable

Contact Lens for Moderate to High Myopia

Preoperativ

e1 Week 1 Month 3 Months 6 Months 12 Months 24 Months

n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)Nuclear

color

Clear (0)407/5

23

(77.8

%)

388/5

01

(77.4

%)

388/5

04

(77.0

%)

368/4

81

(76.5

%)

359/4

68

(76.7

%)

322/4

26

(75.6

%)

163/2

57

(63.4

%)

Trace

(0.5)

115/5

23

(22.0

%)

112/5

01

(22.4

%)

115/5

04

(22.8

%)

112/4

81

(23.3

%)

108/4

68

(23.1

%)

103/4

25

(24.2

%)

93/25

7

(36.2

%)

Mild (1) 0/523(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Moderat

e (1.5 to

2)

1/523(0.2%

)1/501

(0.2%

)1/504

(0.2%

)1/481

(0.2%

)1/468

(0.2%

)1/426 (0.2%) 1/257 (0.4%)

Marked

(>2)0/523

(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Nuclear

Opalesce

nce

Clear (0)400/5

23

(76.5

%)

386/5

01

(77.0

%)

386/5

04

(76.6

%)

370/4

81

(76.9

%)

360/4

68

(76.9

%)

329/4

26

(77.2

%)

165/2

57

(64.2

%)

Trace 119/5 (22.8 112/5 (22.4 115/5 (22.8 108/4 (22.5 105/4 (22.4 95/42 (22.3 91/25 (35.4
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE7http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE8http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE8http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE7http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y


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Preoperativ


n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)

(0.5) 23 %) 01 %) 04 %) 81 %) 68 %) 6 %) 7 %)

Mild (1) 3/523(0.6%

)

2/501(0.4%

)

2/504(0.4%

)

2/481(0.4%

)

2/468(0.4%

)

1/426 (0.2%) 0/257 (0.0%)

Moderat

e (1.5 to

2)

1/523(0.2%

)1/501

(0.2%

)1/504

(0.2%

)1/481

(0.2%

)1/468

(0.2%

)1/426 (0.2%) 1/257 (0.4%)

Marked

(>2)0/523

(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Cortical

Clear (0)495/5

23

(94.6

%)

491/5

01

(98.0

%)

495/5

04

(98.2

%)

473/4

81

(98.3

%)

459/4

68

(98.1

%)

417/4

26

(97.9

%)

257/2

57

(100.0

%)

Trace

(0.5)

26/52

3

(5.0%

)9/501

(1.8%

)8/504

(1.6%

)7/481

(1.5%

)7/468

(1.5%

)8/426 (1.9%) 0/257 (0.0%)

Mild (1) 1/523 (0.2%)

1/501 (0.2%)

1/504 (0.2%)

0/481 (0.0%)

1/468 (0.2%)

1/426 (0.2%) 0/257 (0.0%)

Moderat

e (1.5 to

2)

1/523(0.2%

)0/501

(0.0%

)0/504

(0.0%

)1/481

(0.2%

)1/468

(0.2%

)0/426 (0.0%) 0/257 (0.0%)

Marked

(>2)0/523

(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Posterior

subcapsu

lar

Clear (0)

519/5

23

(99.2

%)

499/5

01

(99.6

%)

502/5

04

(99.6

%)

480/4

81

(99.8

%)

467/4

68

(99.8

%)

426/4

26

(100.0

%)

257/2

57

(100.0

%)Trace

(0.5)4/523

(0.8%

)2/501

(0.4%

)2/504

(0.4%

)1/481

(0.2%

)1/468

(0.2%

)0/426 (0.0%) 0/257 (0.0%)

Mild (1) 0/523(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Moderat

e (1.5 to

2)

0/523(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Marked

(>2)0/523

(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

Anterior

Subcapsu

lar

Clear (0)519/5

23

(99.2

%)

475/5

01

(94.8

%)

482/5

04

(95.6

%)

459/4

81

(95.4

%)

447/4

68

(95.5

%)

398/4

26

(93.4

%)

238/2

57

(92.6

%)

Trace

(0.5)4/523

(0.8%

)

21/50

1

(4.2%

)

17/50

4

(3.4%

)

18/48

1

(3.75

%)

15/46

8

(3.2%

)

22/42

6(5.2%)

13/25

7(5.1%)

Mild (1) 0/523(0.0%

)3/501

(0.6%

)2/504

(0.4%

)2/481

(0.4%

)4/468

(0.9%

)2/426 (0.5%) 4/257 (1.6%)


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Preoperativ


n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)

Moderat

e (1.5 to

2)

0/523(0.0%

)2/501

(0.4%

)3/504

(0.6%

)2/481

(0.4%

)2/468

(0.4%

)4/426 (0.5%) 2/257 (0.8%)

Marked

(>2)0/523

(0.0%

)0/501

(0.0%

)0/504

(0.0%

)0/481

(0.0%

)0/468

(0.0%

)0/426 (0.0%) 0/257 (0.0%)

n/N =

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Fourteen cases (2.7%) of AS lens opacities greater than trace have been reported in the ICL for myopia clinical

study. Most of these lens opacities have been asymptomatic (patients are unaware of their presence) not

affecting vision or requiring any treatment. AS lens opacities greater than trace (>0.5 LOCS) can generally be

divided into two groups; those occurring early (90 days postoperatively) and those occurring late ( 1 year

postoperatively).

Early (first seen 90 days) AS opacities

Early AS lens opacities occurred in 12 cases (1.9%); 75% were asymptomatic. These early cases seem to be due

to surgically induced trauma and the surgeons learning curve. One case caused by a miotic with preservative

irrigated into the anterior chamber at the time of surgery progressed to ICL removal, cataract extraction, and

subsequent IOL implantation because of glare and loss of BSCVA. Eight of these 12 cases (67%) were first

observed during the first postoperative week.

Late ( 1 year) AS opacities

Late AS opacities (1 year) were reported in two eyes (0.4%). In the first case, the vault seemed adequate, but

a 1.5+ AS opacity was noted 1 year after ICL surgery, which required ICL removal and cataract extraction/IOL

implantation. A second case (LOCS 1.0+) resulting from surgical trauma during a lens replacement ultimately

led to ICL removal but no crystalline lens extraction. There was no loss of BSCVA, and the patient was

asymptomatic.

Subjective assessments

Patients were asked to complete a self-administered standardized questionnaire both before ICL surgery and at

the 12-month follow-up window. Of the 406 patients who answered the patient subjective evaluation

questionnaire at 1 year, 92.4% (375 of 406) reported that they were very/extremely satisfied with the results of

their surgery; only 1.0% (4 of 406) reported that they were unsatisfied. One unsatisfied patient had the

preservative-containing irrigating solution at surgery, two were left mildly hyperopic, and one complained of

difficulty wearing contacts for residual myopia.

Patients were asked to report on the change in their subjective symptoms 12 months after surgery compared

with before ICL implantation (Table 9). In terms of quality of vision, glare, double vision, and night driving

difficulties, slightly more patients reported an improvement in these symptoms compared with their baselinescores. For haloes, there was a less than 3.0% difference between the percent of patients reporting an

improvement versus a worsening in this symptom

Table 9. Change in Subjective Patient Symptoms (Preoperative to 12-month Postoperative in Patients with an

Implantable Contact Lens for Moderate to High Myopia)

Quality of Vision Glare Haloes Double Vision Night Driving

n % n % n % n % n %

Improved 2 categories 23 (5.7%) 10 (2.5%) 12 (2.9%) 2 (0.5%) 17 (4.3%)
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE8http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE9http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE9http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE8http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y


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Quality of Vision Glare Haloes Double Vision Night Driving

n % n % n % n % n %

Improved 1 category 105 (25.9%) 39 (9.6%) 29 (7.1%) 4 (1.0%) 37 (9.4%)

No change 236 (58.3%) 325 (79.9%) 314 (77.1%) 397 (97.5%) 309 (78.4%)

Worsened 1 category 39 (9.6%) 30 (7.4%) 38 (9.3%) 4 (1.0%) 23 (5.8%)

Worsened 2 category 2 (0.5%) 3 (0.7%) 14 (3.4%) 0 (0.0%) 8 (2.0%)Full-size table

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Discussion

The 12-month clinical outcomes presented in this report from the ongoing U. S. FDA ICL Clinical Study for

Myopia provide further assurance regarding the safety, effectiveness, and stability of the refractive ICL

approach for the correction of moderate to high myopic refractive errors.

In this section, current results from the U.S. FDA ICL Clinical Study for Myopia will be discussed supplemented

by background data from earlier reports of international ICL series. Furthermore, to provide a more thorough

analysis of the potential value of the ICL in our armamentarium of refractive surgical alternatives, ICL clinicalstudy outcomes will be contrasted to the safety and effectiveness data available for FDA-approved myopic PRK

and LASIK clinical studies. The excimer data presented have been reported in the published Safety and

Effectiveness Summaries of the approved Premarket Approval Applications made available from the FDA

through the Freedom of Information Act.32, 33, 34, 35, 36, 37, 38, 39, 40 and 42

Table 10summarizes the primary safety and efficacy variables for all excimer laser approvals for myopic or

myopic astigmatism PRK where data have been stratified by the level of preoperative MRSE to allow for a

review specifically of moderate to high myopia (>6 or >7 D depending on the study).

Table 10. Comparison of U. S. Implantable Contact Lens Study to U.S. Food and Drug Administration-approved

Photorefractive Keratectomy Premarket Approval Applications Summary of Safety and Effectiveness

ParameterU.S. Food and Drug

AdministrationLaserSight Nidek Autonomous

ProcedureImplantable Contact

Lens

Photorefractive

Keratectomy

Photorefractive

Keratectomy

Photorefractive

Keratectomy

Myopia range (D) 3.0 to 20.0 D SE 6.0 to 10.0 D SE7.0 to 13.00 D

SE

7.0 to 10.0 D

sphere

Mean preoperative

myopia (D)10.05 3.75 NR NR NR

Follow-up 12 mos 6 and 12 mos 6 mos 6 and 12 mos

Number of cases 523 eyes 544 eyes 587 eyes 476 eyes*

Predictability

0.50 D 61.6% (12 mos) 32.5% (6 mos) 42.8% (6 mos) 60.0% (6 mos)

35.0% (12 mos) 1.0 D 84.7% (12 mos) 52.6% (6 mos) 68.3% (6 mos) 76.7% (6 mos)

60.0% (12 mos)

2.0 D 96.7% (12 mos) 90.4% (6 mos) 86.2% (6 mos) NR

86.7% (12 mos)

UCVA

20/40 or better 92.5% (12 mos) 67.0% (6 mos) 80.7% (6 mos) 86.2% (6 mos)

69.1% (12 mos)
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE9http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB32http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB33http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB34http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB35http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB36http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB37http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB38http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB39http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB40http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB42http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE10http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN2http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN1http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TBLFN2http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE10http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB42http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB40http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB39http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB38http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB37http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB36http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB35http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB34http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB33http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB32http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE9http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y


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AdministrationLaserSight Nidek Autonomous

ProcedureImplantable Contact

Lens

Photorefractive

Keratectomy

Photorefractive

Keratectomy

Photorefractive

Keratectomy

20/20 or better 60.1% (12 mos) 32.1% (6 mos) 45.5% (6 mos) 48.3% (6 mos)

21.9% (12 mos)

Loss of BSCVA> 2 lines 0.2% (12 mos) 0.9% (6 mos) 3.5% (6 mos) NR

3.3% (12 mos)

BSCVA = best spectacle-corrected visual acuity; D = diopter; SE = spherical equivalent; NR = not reported; UCVA

= uncorrected visual acuity.

Best spectacle-corrected visual acuity 20/20 or better preoperative.

*

Sphere only eyes.

Full-size table

Table options

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Table 11summarizes the primary safety and efficacy variables for all excimer laser approvals for LASIK where

data have been stratified by the level of preoperative MRSE to allow for a review specifically of moderate to

high myopia (>6 or >7 D depending on the study). These higher myopia data were selected for comparison with

the ICL study because in the latter only 21.2% of eyes had a preoperative myopia less than 7 D, whereas 9.9%

had more than 15 D.

Table 11. Comparison of U.S. Implantable Contact Lens Study to U.S. Food and Drug AdministrationApproved

LASIK


AdministrationNidek Autonomous

Procedure Implantable ContactLens

Laser In SituKeratomileusis

Laser In Situ Keratomileusis

Myopia range (D) 3.0 to 20.0 D SE>7.0 to 20.0 D sphere

4.0 D cyl

7.0 to 11.0 D sphere

0.50 to 2 lines 0.2% (12 mos) NR 4.5% (3 mos)
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BSCVA = best spectacle-corrected visual acuity; D = diopters; NR = not reported; SE = spherical equivalent;

UCVA = uncorrected visual acuity.

*

Sphere only eyes.

Best spectacle-corrected visual acuity 20/20 or better preoperative.

Full-size table

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Download as CSV

Safety of the STAAR ICL

From the perspective of safety, preliminary results from the 10-patient phase I U. S. FDA study demonstrated

the potential of the ICL for providing a safe, reversible means of correcting moderate to high myopia. Sanders

et al19 reported an improvement in BSCVA after ICL implantation with no accompanying intraoperative or

postoperative complications. Preservation of BSCVA, commonly considered the primary criterion for assessing

the safety of a refractive surgical procedure, was extremely high in the larger study cohort presented in this

article. Not only maintenance but also an improvement in best-corrected vision (20/20 or better) was achieved

at 6 (83.7%) and 12 months (82.4%) compared with preoperative levels (67.7%). Only one eye (0.2%) lost more

than 2 lines at any postoperative visit through 24 months, a result of a cataract caused by preservative-containing solution irrigated into the anterior chamber. After cataract extraction, vision returned to 20/20.

Previously published ICL reports have also documented this unique improvement in best-corrected vision after

implantation. BSCVA was maintained or improved in all eyes in these series (Gonvers et al,21 Menezo et al,22

and Pesando et al,23), whereas only one eye with a loss was reported by Assetto et al24 and Zaldivar et al.25 In

the U.S. ICL study, BSCVA improved 2 lines in 7% of eyes and more than 2 lines in an additional 2.6% of eyes at

12 months.

Loss of BSCVA (>2 lines) in the current ICL study (0.2% for all postoperative visits) was better than all excimer

PRK studies (0.9%, 3.3%, 3.5%) and better or comparable to all LASIK studies (0%, 3.3%, 4.5%).

Secondary surgeries, adverse events, and surgical complications, as anticipated, were rare in the U.S. ICL

clinical study. The surgical technique closely resembles standard cataract extraction and IOL placement, and

therefore the ICL surgical technique learning curve was expected and shown to be very short.Secondary surgeries involving the ICL were performed in only 12 eyes (2.3%) with no loss of best-corrected

vision observed in these cases. These secondary ICL surgeries (2.3%) in combination with the 15 cases (2.9%)

undergoing LASIK could be thought of as an enhancement rate when comparing the ICL with LASIK. Surgical

complications were rare, largely involving flipping and reinserting the lens during the initial ICL implantation

(2.1%). Furthermore, as previously reported in the literature, the safety of the ICL procedure is enhanced by

the low incidence of postoperative and intraoperative complications.19, 25 and 28

The only complications observed after ICL implantation occurred within the first 6 months after surgery, with

an absence of any long-term complications reported. Only three (0.6%) complications were reported from 1 to

6 months after ICL implantation in the 523 study eyes; no complications were reported after the 6-month visit

through 24 months. Postoperative complications included one retinal detachment repair at 6 months, one

failed attempt to correct a slight ovalization of the pupil with argon laser synechiolysis at 6 months, and one

treatment of an acute retinal hole at 3 months postoperatively. There was one iris prolapse repair 1 day after

surgery.

Acute pressure rises that occurred in the early postoperative period were managed effectively by

postoperative yttriumaluminumgarnet laser iridotomies, surgical iridectomies, or anterior chamber irrigation

in 4.1% of cases. All pressures returned to normal after these procedures. Of note, no patients in the study

cohort required long-term glaucoma medication, and there was no significant late elevation in IOP (0.4%) after

implantation of the ICL for myopia.

Reports of lens opacities/cataract development after implantation of earlier versions of the ICL have been

published from international series.31 and 41 Data from these European series in most cases involved the use
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE11http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB21http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB22http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB23http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB24http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB25http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB25http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB28http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB31http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB41http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB41http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB31http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB28http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB25http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB25http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB24http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB23http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB22http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB21http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#TABLE11http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=yhttp://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y


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of the V3 and C3 ICL designs, which had substantially less vault, rather than the V4 ICL lens design discussed in

this report.

On the basis of these earlier reports, to adequately evaluate the incidence of lens opacities in this study, the

standardized LOCS III grading system for lens opacities was used across all centers. With the exception of AS

changes, the distribution of all other parameters remained unchanged (trace nuclear color, trace nuclear

opalescence, cortical or posterior subcapsular).

A small number of lens opacities were reported with this newer version of the ICL. Most importantly, of the 12

early AS lens opacities that were identified, most (8 of 12 or 67%) occurred in the first week after surgery, and

most cases were asymptomatic (75%). These early AS opacities seem to be due to surgically induced trauma

and the surgeons learning curve and are detected almost immediately after surgery during the initial healing

phase.

The key question therefore has been whether a progressive/late lens opacification is associated with the ICL

procedure. Late AS opacities (1 year) were reported in only two cases, (0.4%), and only one of these was likely

due to improper sizing of the ICL length. Longer term follow-up may be necessary to fully evaluate the real risk

of clinically significant late AS opacities.

The incidence of subjective patient symptoms showed a slight improvement (glare, double vision, quality of

vision, night driving difficulties) compared with before surgery in contrast to other refractive surgery

procedures in which large increases in symptoms are commonly reported.

In summary, the outcomes of this study clearly support the overall short-term and intermediate-term safety ofICL surgery. Both intraoperative and postoperative complications were low, no late complications were

reported, and ICL surgery did not preclude a successful subsequent cataract extraction and IOL implantation in

this patient population. The incidence of best-corrected vision loss (>2 lines) is substantially lower than PRK

rates and lower than or comparable to approved U.S. LASIK studies, despite the large proportion of high

myopes in the ICL clinical study. Preservation and even improvement of best-corrected vision is a key benefit of

this technique.

Effectiveness of the STAAR myopia ICL

Preliminary data from the phase I U.S. FDA ICL clinical study reported 80% of eyes within 0.25 D of

emmetropia in conjunction with 100% of eyes 20/30 or better UCVA.19

The U.S. ICL clinical study involved the enrollment of patients with myopia (MRSE) up to 20.00 D and a highest

lens power of 20.00 D, resulting in intended undercorrection in the higher myopes.UCVA, the primary efficacy variable for the ICL clinical study and most refractive surgeries, showed great

improvement over preoperative values. A mean line improvement between the 1-year and preoperative visits

was 10.31 lines. Uncorrected acuity improved in the immediate first postoperative week and remained stable

throughout the follow-up period, supporting the value of the implantable lens concept.

Uncorrected vision jumped from 0% of patients with 20/80 or better to 89.1% with 20/40 or better at 1 week;

with a slight continued improvement over the follow-up period (92.1% [6 months], 92.5% [12 months], and

93.3% [24 months]). The proportion of eyes with 20/20 or better also showed a substantial improvement,

rising from 0% preoperatively to 60.1% at 1 year.

These results with the ICL are better or comparable to those reported in the approved excimer studies. For

PRK, the proportion of eyes 20/20 or better ranged from 21.9% to 48.3% compared with a higher rate of 60.1%

with the ICL. The ICL outcome (92.5%) was also better at 20/40 or better compared with PRK percentages of

69.1% to 86.2%. The ICL was better or comparable to LASIK outcomes with the incidence of 20/20 or better

ranging from 14.6% to 71.4% (ICL: 60.1%) and 20/40 or better ranging from 67.1% to 93.6% (ICL: 92.5%). The

ICL percentage was better than all but one LASIK study for both 20/20 and 20/40 or better UCVA. Again, the

degree of preoperative myopia was substantially higher in the ICL cases than in the LASIK cases.

Predictability with the ICL is excellent and compares favorably with both PRK and LASIK outcomes. ICL results at

all three predictability breakdowns ( 0.50 D, 1.0 D, and 2.0 D) were better than all reported PRK

studies. The proportion of eyes with 0.50 D in the ICL study was 61.6% compared with that of PRK (32.5%,

35.0%, 42.8%, and 60.0%). For eyes within 1.0 D, again the ICL had a higher percentage of cases (84.7%)
http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19http://offcampus.tums.ac.ir:2058/science/article/pii/S0161642002017712?np=y#BIB19


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compared with that of PRK, ranging between 52.6% and 76.7%. Within 2.0 D of the attempted correction, PRK

studies were between 86.2% and 90.4%, lower than the 96.7% reported in the ICL study.

Comparing the ICL and LASIK predictability outcomes, the proportion of eyes falling within 0.50 D, 1.0 D,

and 2.0 D were better than the reported LASIK figures in most studies and comparable to all LASIK studies.

For 0.50 D of the attempted correction, 61.6% of ICL cases fell in this range compared with LASIK (42.3%,

44.2%, 47.2%, 60.6%, 64.5%). In the ICL study, 84.7% fell within 1.0 D compared with between 62.5% and

86.4% in the LASIK studies; the ICL better than all but one study). And for the proportion of eyes falling within 2.0 D, the ICL outcome of 96.7% was better than all but one LASIK study (83.9% to 100%).

Subjective patient satisfaction was high 1 year after ICL surgery, reflecting the positive acceptance of this

procedure by the moderate and high myopic patient population, who currently have fewer optimal alternatives

for the correction of their high refractive errors. At 1 year, 92.4% reported that they were very/extremely

satisfied with the results of their surgery; only 1.0% stated that they were unsatisfied.

In summary, this study leads to the conclusion that the current ICL design offers a safe, effective, and stable

alternative for the correction of moderate to high myopia. These clinical outcomes are better or comparable to

existing refractive surgery alternatives.

Appendix.

The Implantable Contact Lens for Myopia (ITM) Study Group

The participants in the ITM Study Group as of October 2001 are as follows:

John A. Vukich, MD,* Davis Duehr Dean Medical Center, Madison, Wisconsin

Donald R. Sanders, MD, PhD,* andKimberley Doney, MBA, Center for Clinical Research, Chicago, Illinois

Ronald Barnett, MD, David Dulaney, MD, Scott Perkins, MD, The Barnett Dulaney Eye Center, Phoenix, Arizona

Sheri L. Rowen, MD, Rowen Laser Vision & Correction Center, Towson, Maryland

Douglas Steel, MD, Advance Sight Medical Group, Los Angeles, California

Ralph Berkeley, MD, Michael Caplan, MD, Paul Mann, MD, Houston Microsurgery Center, Houston, Texas

Stephen Bylsma, MD, Shepard Eye Center, Santa Maria, California

R. Gale Martin, MD, Carolina Eye Associates, Southern Pines, North Carolina

David C. Brown, MD, Eye Centers of Florida, Fort Myers, Florida

Harry Grabow, MD, Sarasota Cataract Institute, Sarasota, Florida

Charles H. Williamson, MD, Williamson Eye Center, Baton Rouge, Louisiana

John R. Shepherd, MD, Shepherd Eye Center, Las Vegas, NevadaHoward Fine, MD, Oregon Eye Surgery Center, Eugene, Oregon

Manus Kraff, MD, Kraff Eye Institute, Chicago, Illinois

Robert Fabricant, MD, Pacific Eye Institute, Upland, California

Alan Berg, MD, Advanced Vision Correction Centers, Burbank, California

Monica Gaston, Nancy Hall, Darcy Smith, STAAR Surgical, Monrovia, California

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Manuscript no. 210619.

Supported by STAAR Surgical, Monrovia, California.

Reprints requests to Darcy Smith, STAAR Surgical Company, 1911 Walker Avenue, Monrovia, CA 91016, USA.

*

The Appendix lists participants of the Study Group.

*

Dr. Vukich, Dr. Bylsma, Dr. Brown, and Dr. Sanders are paid consultants to STAAR Surgical

Dr. Sanders, Dr. Vukich, Ms. Doney, and Ms. Gaston participated in the writing of this manuscript.

Copyright 2003 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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sanders dr clinical trial of the implantable contact lens for moderate to high myopia

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