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Intracameral Intracameral Dilation Dilation (Still A Work in Progress) (Still A Work in Progress) Steven Dewey, MD Steven Dewey, MD Colorado Springs, CO Colorado Springs, CO Consultant to AMO Consultant to AMO Royalties from MST Royalties from MST With Significant Assistance from Nathan Dewey With Significant Assistance from Nathan Dewey

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Page 1: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

IntracameralIntracameral DilationDilation(Still A Work in Progress)(Still A Work in Progress)

Steven Dewey, MDSteven Dewey, MDColorado Springs, COColorado Springs, CO

Consultant to AMOConsultant to AMORoyalties from MSTRoyalties from MST

With Significant Assistance from Nathan DeweyWith Significant Assistance from Nathan Dewey

Page 2: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Intracameral Dilation RegimenIntracameral Dilation Regimen

•• Innovators in intracameral injections for dilationInnovators in intracameral injections for dilation–– Cionni, et alCionni, et al11——IC lidocaine (supplemented with epinephrine)IC lidocaine (supplemented with epinephrine)–– Lundberg and BehndigLundberg and Behndig2,32,3——IC lidocaine, phenylephrine, and IC lidocaine, phenylephrine, and

cyclopentolate, then IC lidocaine and phenylephrine without cyclocyclopentolate, then IC lidocaine and phenylephrine without cyclo–– Myers & ShugarMyers & Shugar——IC ”EpiIC ”Epi--Shugarcaine” with preoperative tropicamideShugarcaine” with preoperative tropicamide

•• Trends for intracameral injection: Trends for intracameral injection: –– Faster acting agents (shorter halfFaster acting agents (shorter half--life)life)–– Lidocaine is a common thread Lidocaine is a common thread

•• Relaxes iris sphincterRelaxes iris sphincter–– Parasympathetic antagonists Parasympathetic antagonists

•• Tropicamide preoperativelyTropicamide preoperatively•• Cyclopentolate intraoperativelyCyclopentolate intraoperatively

–– Sympathetic agonists Sympathetic agonists •• Epinephrine Epinephrine •• Phenylephrine (Europe and Canada)Phenylephrine (Europe and Canada)

11Cionni, RJ; Barros, MG; Kaufman, AH; Osher, RH. Cataract surgery without preoperative eyedrops. J Cataract Refract Surg. 2003;29:2281–3. 22Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg 2003; 29:2366–23713 3 Lundberg B, Behndig A. Separate and additive mydriatic effects of lidocaine hydrochloride, phenylephrine, and cyclopentolate after intracameral injection. J Cataract Refract Surg. 2008 Feb;34(2):280-3. 44W. Myers, J. Shugar; Optimizing the intracameral dilation regimen for cataract surgery: Prospective randomized comparison of W. Myers, J. Shugar; Optimizing the intracameral dilation regimen for cataract surgery: Prospective randomized comparison of 2 s2 solutions. J olutions. J Cataract Refract Surg. 2009 Feb;35(2):273Cataract Refract Surg. 2009 Feb;35(2):273--66

Page 3: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

The Weak Link in DilationThe Weak Link in Dilation

•• Topical phenylephrine (PE) compared to intracameral Topical phenylephrine (PE) compared to intracameral epinephrineepinephrine–– Is less potent at alpha receptors for dilationIs less potent at alpha receptors for dilation1,21,2

–– Has far weaker betaHas far weaker beta--adrenergic effect to relax iris sphincteradrenergic effect to relax iris sphincter3,43,4

–– Longer halfLonger half--life means slower onset of effectlife means slower onset of effect–– Impedes the effectiveness of intracameral epinephrine by Impedes the effectiveness of intracameral epinephrine by

blocking iris receptorsblocking iris receptors•• In patients on betaIn patients on beta--blockers:blockers:

–– Systemic absorption can cause significant hypertension due Systemic absorption can cause significant hypertension due to vasoconstriction from the unopposed alphato vasoconstriction from the unopposed alpha--adrenergic adrenergic effecteffect3,43,4 (can be seen with calcium channel blockers as well)(can be seen with calcium channel blockers as well)

–– BetaBeta--blockade extends to iris sphincter making the lessblockade extends to iris sphincter making the less--active active PE a poorer choice for dilationPE a poorer choice for dilation3,43,4

11Ohkobu K, Chiba S. Responses of isolated canine ophthalmic and ciliary arteries to vasoactive substances. Jpn J Ophthalmol. 1Ohkobu K, Chiba S. Responses of isolated canine ophthalmic and ciliary arteries to vasoactive substances. Jpn J Ophthalmol. 1988988;31:627;31:627--634. 634. 22Green K, Lollis G. Response of the isolated rabbit ciliary epithelium to adrenergic drugs following superior cervical ganglioGreen K, Lollis G. Response of the isolated rabbit ciliary epithelium to adrenergic drugs following superior cervical ganglionecnectomy. Curr Eye Res. 1982;1:217tomy. Curr Eye Res. 1982;1:217--222.222.33Geyer O; Bar-Ilan A; Beta3-adrenergic relaxation of bovine iris sphincter. FEBS letters 1998;429(3):356-8. 4 4 Katzung Bertram G Basic & Clinical Pharmacology Chapter 9, Pg 13355Kalyanaraman, M., et al., Cardiopulmonary compromise after use of topical and submucosal alpha- agonists: possible added complication by the use of beta-blocker therapy. Otolaryngol Head Neck Surg, 1997. 117(1): p. 56-61. 66Groudine, S.B., et al., New York State guidelines on the topical use of phenylephrine in the operating room. The Phenylephrine Advisory Committee. Anesthesiology, 2000. 92(3): p. 859-64.

Page 4: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Intracameral DilationIntracameral Dilation(2009) A non(2009) A non--matched study found the following:matched study found the following:

–– We can eliminate phenylephrine from the preoperative topical regimenWe can eliminate phenylephrine from the preoperative topical regimen–– We can’t use intracameral tropicamide to We can’t use intracameral tropicamide to replacereplace topical tropicamide.topical tropicamide.–– But, intracameral tropicamide may But, intracameral tropicamide may supplementsupplement topical tropicamide.topical tropicamide.

(2010) Based on these findings, consideration was given to the following (2010) Based on these findings, consideration was given to the following subjective/objective observationssubjective/objective observations

–– Diluted lidocaine did not provide as effective anesthesia 1% lidocaineDiluted lidocaine did not provide as effective anesthesia 1% lidocaine–– Diluted epinephrine did not stabilize the stroma as effectivelyDiluted epinephrine did not stabilize the stroma as effectively

The following regimen was created: The following regimen was created: •• IC Tropicamide .1% with 1% Lidocaine and halfIC Tropicamide .1% with 1% Lidocaine and half--strength Epinephrine strength Epinephrine

–– Supplemented by preSupplemented by pre--operative topical 1% tropicamide (“IC Tropicamide Mix”)operative topical 1% tropicamide (“IC Tropicamide Mix”)(compounded .2% tropicamide and 2% lidocaine mixed 50:50 with non(compounded .2% tropicamide and 2% lidocaine mixed 50:50 with non--preserved epinephrine)preserved epinephrine)

•• Compared in a fellow eye study to preoperative topical 1% Cyclopentolate and 10% Compared in a fellow eye study to preoperative topical 1% Cyclopentolate and 10% Phenylephrine (with 1% IC Lidocaine) (“Topical Drops”)Phenylephrine (with 1% IC Lidocaine) (“Topical Drops”)

•• 24 patients (11F, 13M), ave age 73.8 (+/24 patients (11F, 13M), ave age 73.8 (+/-- 7.3 yrs)7.3 yrs)•• All surgeries carried out between October, 2009 and March, 2010 and spaced no more All surgeries carried out between October, 2009 and March, 2010 and spaced no more

than one month apart.than one month apart.•• Although tamsulosin was not specifically evaluated in the study, two patients were Although tamsulosin was not specifically evaluated in the study, two patients were

dropped from the evaluation for starting tamsulosin between the performance of the dropped from the evaluation for starting tamsulosin between the performance of the two surgeries. (Neither informed our office specifically, but one notified the surgery two surgeries. (Neither informed our office specifically, but one notified the surgery center upon arrival)center upon arrival)

•• The assumption is that all other medications were the same between the two surgeries The assumption is that all other medications were the same between the two surgeries (and gender as well . . .)(and gender as well . . .)

Page 5: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Tested Regimens Tested Regimens (so far)(so far)

(2009) Intracameral Regimen Study(2009) Intracameral Regimen Study•• IC Lidocaine IC Lidocaine

–– With cyclopentolate .1% and phenylephrine 1% (13m, 8f, ave 72.4 yo) (Note: With cyclopentolate .1% and phenylephrine 1% (13m, 8f, ave 72.4 yo) (Note: Lundberg/Behndig solution contained 1.5% PE)Lundberg/Behndig solution contained 1.5% PE)

•• IC Lidocaine & Epinephrine (EpiIC Lidocaine & Epinephrine (Epi--Shugarcaine)Shugarcaine)–– Alone (9m, 15f, ave 74.5 yo) Alone (9m, 15f, ave 74.5 yo) –– With topical tropicamide (5m, 9f, ave 72.1 yo)With topical tropicamide (5m, 9f, ave 72.1 yo)

•• IC Tropicamide with EpiIC Tropicamide with Epi--ShugarcaineShugarcaine–– With .1% intracameral tropicamide (8m, 23f, 71.6 yo)With .1% intracameral tropicamide (8m, 23f, 71.6 yo)–– With topical and .05% intracameral tropicamide (10m, 8f, ave 74.8 yo)With topical and .05% intracameral tropicamide (10m, 8f, ave 74.8 yo)–– With topical and .1% intracameral tropicamide (3m, 4f, ave 71.6 yo)With topical and .1% intracameral tropicamide (3m, 4f, ave 71.6 yo)

•• Each regimen was tested on a per day basisEach regimen was tested on a per day basis–– Fellow eye studies impractical when trying to evaluate a number of different Fellow eye studies impractical when trying to evaluate a number of different

combinations rather than a headcombinations rather than a head--toto--head comparison of two different agents head comparison of two different agents or combinations of agentsor combinations of agents

(2010) Fellow Eye Study (2010) Fellow Eye Study (11f, 13m, ave 73.8 yo)(11f, 13m, ave 73.8 yo)

•• Compounded Topical DropsCompounded Topical Drops–– 1% Cyclopentolate & 10% Phenylephrine1% Cyclopentolate & 10% Phenylephrine–– Supplemented with 1% IC LidocaineSupplemented with 1% IC Lidocaine

•• IC Tropicamide .1% with 1% Lidocaine and halfIC Tropicamide .1% with 1% Lidocaine and half--strength Epinephrinestrength Epinephrine–– Supplemented by preSupplemented by pre--operative topical 1% tropicamideoperative topical 1% tropicamide

Page 6: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Measuring Pupil DilationMeasuring Pupil Dilation

•• Using the “software ruler” of the Surgical Media Center (SMC) from Using the “software ruler” of the Surgical Media Center (SMC) from Abbot Medical Optics, each of the following stages in cataract surgery Abbot Medical Optics, each of the following stages in cataract surgery was measured for each of the tested regimens. (seconds gives a rough was measured for each of the tested regimens. (seconds gives a rough interval after the start of the case)interval after the start of the case)

–– At start of procedure (15 sec)At start of procedure (15 sec)–– After first agent instillation (60 sec)After first agent instillation (60 sec)–– After second agent instillation (90 sec) (2009 testing only)After second agent instillation (90 sec) (2009 testing only)–– Viscomydriasis/Capsulorhexis (2 min)Viscomydriasis/Capsulorhexis (2 min)–– MidMid--Phacoemulsification (3 min)Phacoemulsification (3 min)–– MidMid--IOL insertion (5 min)IOL insertion (5 min)–– End of Case (6 to 7 min)End of Case (6 to 7 min)

•• Length of procedure also compared between regimensLength of procedure also compared between regimens–– Speed of dilation will improve the efficiency of the surgerySpeed of dilation will improve the efficiency of the surgery–– Effective pupil size and tone will speed the surgery as wellEffective pupil size and tone will speed the surgery as well

•• Cases were eliminated in 2009 and 2010 if the pupil size was not Cases were eliminated in 2009 and 2010 if the pupil size was not captured for accurate measurementcaptured for accurate measurement

–– Surgical case too far offSurgical case too far off--screenscreen–– Video did not get started, or did not get started on timeVideo did not get started, or did not get started on time

Page 7: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

The SMC Software RulerThe SMC Software Ruler

PrePre--dilation IC Epidilation IC Epi--Shugarcaine IC Tropicamide .1%Shugarcaine IC Tropicamide .1%

Capsulorhexis Phacoemulsification IOL Implantation End of CaseCapsulorhexis Phacoemulsification IOL Implantation End of Case

Page 8: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Relative Dilation FailuresRelative Dilation Failures

Defined a failure to dilate at 6 mm (an arbitrary measurement based on optic diameter)Defined a failure to dilate at 6 mm (an arbitrary measurement based on optic diameter)–– Pupil did not achieve a 6 mm dilationPupil did not achieve a 6 mm dilation–– Pupil did not maintain a 6 mm dilation from phacoemulsification to the end of Pupil did not maintain a 6 mm dilation from phacoemulsification to the end of

the casethe case2009 Intracameral Dilation Study2009 Intracameral Dilation Study•• IC cyclopentolate/PE failed in 6 of 21 (3m, 3f) cases IC cyclopentolate/PE failed in 6 of 21 (3m, 3f) cases

–– Most billowing of the iris stroma of any regimenMost billowing of the iris stroma of any regimen•• EpiEpi--Shugarcaine dilated quickest, but failed in 8 of 24 cases (3m, 5f)Shugarcaine dilated quickest, but failed in 8 of 24 cases (3m, 5f)

–– Although the pupil was a bit smaller, the iris tone was goodAlthough the pupil was a bit smaller, the iris tone was good•• IC tropicamide .1% dilated slower, but was slightly more effective at retaining IC tropicamide .1% dilated slower, but was slightly more effective at retaining

dilation combined with Epidilation combined with Epi--Shugarcaine (8 of 31, 3m, 5f)Shugarcaine (8 of 31, 3m, 5f)–– Slightly better dilation, iris tone equal to EpiSlightly better dilation, iris tone equal to Epi--Shugarcaine groupShugarcaine group

2010 Fellow2010 Fellow--Eye StudyEye Study•• Topical drops alone failed in 1 of 24 (1m) with 5 (4m, 1f) at less than 6 mm by the Topical drops alone failed in 1 of 24 (1m) with 5 (4m, 1f) at less than 6 mm by the

end of the caseend of the case•• IC Tropicamide mix failed in 2 of 24 (3m, 2f) with 6 (5m, 1f) at less than 6 mm by IC Tropicamide mix failed in 2 of 24 (3m, 2f) with 6 (5m, 1f) at less than 6 mm by

the end of the casethe end of the case•• The single failure in each series to reach 6 mm at any point were fellow eyes of the The single failure in each series to reach 6 mm at any point were fellow eyes of the

same patient (male), however, only three below 6 mm at the end of the case were same patient (male), however, only three below 6 mm at the end of the case were fellow eyes (3m)fellow eyes (3m)

No surgical case in either 2009 or 2010 required a pupilNo surgical case in either 2009 or 2010 required a pupil--expanding device or pupil expanding device or pupil stretching, nor were any eliminated from the study for that reason.stretching, nor were any eliminated from the study for that reason.

Page 9: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Benefits of Topical TropicamideBenefits of Topical Tropicamide

Intracameral Agents Only

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•• Topical tropicamide 1% improved Topical tropicamide 1% improved all measured dilation parameters all measured dilation parameters (38 of 39 successful) compared (38 of 39 successful) compared to intracameral agents alone (p to intracameral agents alone (p <.00005)<.00005)

•• Viscomydriasis was effective with Viscomydriasis was effective with either dispersive viscoelastic used either dispersive viscoelastic used (Viscoat or Healon(Viscoat or Healon--D)D)–– PrePre--op Tropicamide: 0.7 mmop Tropicamide: 0.7 mm–– No Pre Tropicamide: 1.1 mmNo Pre Tropicamide: 1.1 mm

•• Regardless of dilation regimen, Regardless of dilation regimen, average pupil size decreased from average pupil size decreased from phacoemulsification to the end of phacoemulsification to the end of the casethe case–– Average: .75 mmAverage: .75 mm

Page 10: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Topical and IC TropicamideTopical and IC Tropicamide

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•• (2009) Topical tropicamide 1% improved (2009) Topical tropicamide 1% improved all measured dilation parameters for Epiall measured dilation parameters for Epi--Shugarcaine.Shugarcaine.

–– p < .0001 for phaco, IOL and endp < .0001 for phaco, IOL and end--case case measurementsmeasurements

•• (2009) Intracameral tropicamide improved (2009) Intracameral tropicamide improved dilation parameters for Epidilation parameters for Epi--ShugarcaineShugarcaine

–– p < .06 for phacop < .06 for phaco–– p < .05 for endp < .05 for end--casecase

•• (2009) Intracameral tropicamide did not (2009) Intracameral tropicamide did not appear to supplement topical tropicamide appear to supplement topical tropicamide in a statisticallyin a statistically--significant fashion, significant fashion, although although surgical case times were fastersurgical case times were fasterthan without it.than without it.

–– Hence, the 2010 studyHence, the 2010 study•• (2010) The IC Tropicamide Mix resulted in (2010) The IC Tropicamide Mix resulted in

dilation close to that of Topical Drops.dilation close to that of Topical Drops.–– Starting dilation was obviously different (p Starting dilation was obviously different (p

= .00029), as was pupil size just prior to = .00029), as was pupil size just prior to viscoelastic inflation of the anterior viscoelastic inflation of the anterior chamber (p = .08)chamber (p = .08)

–– For capsulorhexis, phacoemulsification, IOL For capsulorhexis, phacoemulsification, IOL implantation and end of case, the dilation implantation and end of case, the dilation was virtually the same (p = .11 to .27)was virtually the same (p = .11 to .27)

•• (2010) No significant differences in iris (2010) No significant differences in iris tone were recorded between the two tone were recorded between the two groups.groups.

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Page 11: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Surgical Procedure TimesSurgical Procedure TimesProcedure times were measured from first incision to completion of the Procedure times were measured from first incision to completion of the

surgerysurgery(2009) Procedure times were inversely related to effectiveness of dilation.(2009) Procedure times were inversely related to effectiveness of dilation.•• IC Lidocaine & Epinephrine (EpiIC Lidocaine & Epinephrine (Epi--Shugarcaine)Shugarcaine)

–– With topical and .1% IC tropicamide: 6:18With topical and .1% IC tropicamide: 6:18–– With topical and .05% IC tropicamide: 6:38With topical and .05% IC tropicamide: 6:38–– With topical tropicamide: 6:42With topical tropicamide: 6:42–– With .1% IC tropicamide: 6:49With .1% IC tropicamide: 6:49–– Alone: 7:04Alone: 7:04

•• IC LidocaineIC Lidocaine–– With cyclopentolate .1% and phenylephrine 1%: 7:26With cyclopentolate .1% and phenylephrine 1%: 7:26

(2010) The current study compared standard topical drops to the specified (2010) The current study compared standard topical drops to the specified intracameral mixture (one step eliminated from 2009 study, probably 20 intracameral mixture (one step eliminated from 2009 study, probably 20 to 30 seconds):to 30 seconds):

•• IC Lidocaine 1%, Tropicamide .1% & halfIC Lidocaine 1%, Tropicamide .1% & half--strength Epinephrinestrength Epinephrine–– With preWith pre--operative tropicamide: 5:24 (std dev 49s)operative tropicamide: 5:24 (std dev 49s)

•• Topical 1% Cyclopentolate/10% PhenylephrineTopical 1% Cyclopentolate/10% Phenylephrine–– With IC Lidocaine: 5:17 (std dev 61s)With IC Lidocaine: 5:17 (std dev 61s)

•• The two tested regimens had no difference in surgical case time, p = .33, The two tested regimens had no difference in surgical case time, p = .33, suggesting no delay in allowing IC agents to work, nor a significant suggesting no delay in allowing IC agents to work, nor a significant difference in iris characteristics to influence surgical time.difference in iris characteristics to influence surgical time.

Page 12: Intracameral Dilation - Pharmacell · • Intracameral dilation is effective for cataract surgery – No significant differences in dilation compared to topical drops – No differences

Conclusions (So Far)Conclusions (So Far)

•• Intracameral dilation is effective for cataract surgeryIntracameral dilation is effective for cataract surgery–– No significant differences in dilation compared to topical dropsNo significant differences in dilation compared to topical drops–– No differences in surgical case times No differences in surgical case times

•• IC agents work quickly (no delay)IC agents work quickly (no delay)•• Iris behavior similar to topical agentsIris behavior similar to topical agents

–– Subjective absence of stinging from topical drops is a benefitSubjective absence of stinging from topical drops is a benefit–– Topical phenylephrine is not necessary on a routine basisTopical phenylephrine is not necessary on a routine basis

•• Higher concentration of epinephrine has an improved effectHigher concentration of epinephrine has an improved effect•• PrePre--operative topical tropicamide 1% enhances the effects of operative topical tropicamide 1% enhances the effects of

all tested intracameral agentsall tested intracameral agents–– IC Tropicamide appears to enhance this effectIC Tropicamide appears to enhance this effect

•• But, physiology will remain variable between individuals But, physiology will remain variable between individuals despite our efforts at standardizationdespite our efforts at standardization–– Very difficult to standardize exposure time of preVery difficult to standardize exposure time of pre--operative operative

topical agents topical agents –– Standard topical drops do sting and the resulting epiphora may Standard topical drops do sting and the resulting epiphora may

dilute the effect of these dropsdilute the effect of these drops