Which is Better: One or Two?(1st & 2nd Eye Cataract Surgery)

Brian Kirk, MS1; Martin de la Presa, MD1; Molly McFadden, MS3

William Weatherholtz, MS2; Keith Dockstader2; Zoya Sandhu, BS1; Zac Flinders, BS1; Austin Bohner, BS1; Kandice Olson, MD4; Robert Langston CRNA MSN4; Derek Sakata, MD4; Shad Roundy, PhD2; Craig Chaya, MD1

1 Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT2 Department of Mechanical Engineering, University of Utah, Salt Lake City, UT

3 Department of Internal Medicine, Epidemiology, University of Utah, Salt Lake City, UT4 Department of Anesthesiology, University of Utah, Salt Lake City, UT

Financial Support: Unrestricted Grant, Research to Prevent Blindness, Inc., New York, NY, to the

Department of Ophthalmology & Visual Sciences, University of Utah.

Introduction

Derek Sakata MDProfessor & Vice Chair

Executive Director, Ambulatory Anesthesiology

Leland O. and Avanelle W. Learned Endowed Professorship University of Utah, Department of Anesthesiology

Executive Medical Director, Ambulatory Southern Service AreaUniversity of Utah, Health Sciences

Director, Anesthesia ServicesUniversity of Utah, John A. Moran Eye Center

Chair, Faculty Innovation Research & Entrepreneurship (FIRE) ScholarsUniversity of Utah, Center for Medical Innovation

Adjunct Professor, Bio-engineering & Ophthalmology

DisclosuresDerek Sakata MD

• MedVis

– Honorarium for Speaking

• **Axon

– Consultant & Royalties

• Salter Labs

– Consultant

• NuMask

– Free Product for Study

• Becton Dickenson

– Future Study, Intelliport

• Majelco

– Board Position & Stock

• Baxter

– Honorarium for Consulting

DisclosuresDerek Sakata MD

• Founder & Owner

• Single Product

• Past Medical Director

DisclosuresDerek Sakata MD

• Founder & Owner

• Two Products

• Current Medical Director

Introduction

Robert Langston CRNA, MSNUniversity of Utah, John A. Moran Eye Center

DisclosuresRobert Langston CRNA, MSN

None

Background

• With the widespread use of topical anesthesia for cataract surgery, patient comfort and cooperation during surgery is important to the success of the procedure.

• Intraoperative patient cooperation is inversely related to the discomfort they feel.1

• Multiple studies and anecdotal evidence suggest that the patient’s experience with discomfort during cataract surgery can vary between the first and second eye.2,3,4,5,6

Background

• Prior studies:– Primarily subjective measures

(surveys/questionnaires)– Rarely, objective measures

(intraoperative vitals: blood pressure, mean arterial pressure, and heart rate.2

• This study – Primarily objective

measures(novel, hand-held device with transmission of real-time biometric data.

– Secondarily, subjective measures were gathered to compare and give a more complete picture of the patient experience.

Methods

• IRB approved prospective observational study

• Study subjects: single, large volume academic eye center

Inclusion Criteria• >18 years old• Able to receive instruction in

the English language• 1st and 2nd eye surgeries within

6 months of each other• Topical anesthesia

Exclusion Criteria• Surgery performed by resident• Complications or surgery >30

min• Pre-existing condition that

could confound pain analysis• Intraocular non-laser surgery

within 3 mo. of first surgery• Intraocular laser surgery

within 30 days of first surgery

Methods – Objective Data Gathering

• Novel hand-held device • Button for any “discomfort” experienced

during surgery (recorded wirelessly). • Acceleration in x,y, and z planes• Grip force• Skin conductivity • Surgical steps timestamped

intraoperatively (research assistant & correlated to the recorded device data for each subject.

Methods – Subjective Data Gathering• Questionnaires measured subject’s anxiety using State-Trait Anxiety

Inventory (STAI), and pain with a Visual Analog Scale (VAS)

• Surveys: pre-operatively & post-operatively / each surgery

• Final questionnaire: ~1 month following the 2nd eye surgery

Pre-operative

• Anxiety: STAI• Predicted pain: VAS

• Anxiety: STAI• Recalled pain: VAS

Post-operative

Follow-up(1month)

• Satisfaction: surgical experience

• Recall: pain • (1st vs. 2nd surgery)

101 patients enrolled*23 excluded for resident performed surgery, surgical complications etc.

Results

• Only button press was found to be clinically useful for analysis– 6.8 % (1st surgery)

– 8.6 % (2nd surgery)

– Proportional difference: not significant (Chi square, 1 d.f. = 2.7, p = 0.10)

• Surgical steps most associated with click event– Intracameral lidocaine (1st surgery: 11.5% , 2nd surgery: 12.9%)

– Placement of IOL (1st surgery: 19%, 2nd surgery: 23.4%)

• Remembered pain and likelihood of button press:– 1st Surgery: Each 1 pt increase in “Pain Experienced” decreased the

probability of of “zero clicks” by 91% (p=0.01)

– 2nd Surgery: Each 1 pt increase in “Pain Experienced” decreased the probability of “zero clicks” by 60% (p=0.02)

Anxiety Results (Avg. STAI score, max 24)

1st Surgery

Pre-surgery 11.37

Post-surgery 7.88

p=<0.0001*

p=0.0308

2nd Surgery

Pre-surgery 8.56

Post-surgery 7.47

Pain Results (Avg. VAS score, max 10)

1st Surgery

Anticipated pain 1.48

Remembered pain 0.37

Avg. difference 1.26

p=<0.0001*

p=0.0817

2nd Surgery

Anticipated pain 0.41

Remembered pain 0.54

Avg. difference 0.17

*Significantly more pre-op anxiety prior to surgery 1 compared to surgery 2

*Significantly more predicted pain prior to surgery 1 compared to surgery 2

Recalled Pain(Comparison Between 1st & 2nd Surgeries)

Number Percentage

Same 42 53.8%

Less pain 2nd eye 13 16.6%

More pain 2nd eye 20 25.6%

Don’t remember 3 3.8%

Number Percentage

Same 39 59.1%

Less pain 2st eye 9 13.6%

More pain 2st eye 18 27.3%

Don’t remember 0 0%

Right after the 2nd Surgery

3o Days after the 2nd Surgery

Conclusions

• Button Presses– No objective difference between the 1st & 2nd surgery

– Certain surgical steps associated with more

– Reliable reflection of the patient experience, given the increase in likelihood of its use with increased reported pain.

• Between 1st vs. 2nd Surgery– Pre-op anxiety & anticipated pain decreased

– No difference in immediate post-op scoring of pain

• One month following the 2nd surgery– Majority claimed to experience equal amounts of discomfort during

both surgeries.

– Remembering the 1st surgery as more painful increased the than the likelihood to feel the 2nd surgery was more painful

References1.Aslan L, Aslankurt M, Çekic O, Aksoy A, Yildiz H. The pain experience and cooperation of patients in consecutive cataract surgery. Eur J Ophthalmol. 2012;23(3):339-343. doi:10.5301/ejo.5000219

2. Jiang L, Zhang K, He W, Zhu X, Zhou P, Lu Y. Perceived Pain during Cataract Surgery with Topical Anesthesia: A Comparison between First-Eye and Second-Eye Surgery. Journal of Ophthalmology. https://www.hindawi.com/journals/joph/2015/383456/. Published 2015. Accessed March 16, 2018.

3. Adatia FA, Munro M, Jivraj I, Ajani A, Braga-Mele R. Documenting the subjective patient experience of first versus second cataract surgery. Journal of Cataract & Refractive Surgery. 2015;41(1):116-121. doi:10.1016/j.jcrs.2014.04.041

4. Bardocci A, Ciucci F, Lofoco G, Perdicaro S, Lischetti A. Pain during second eye cataract surgery under topical anesthesia: an intraindividual study. Graefes Arch Clin Exp Ophthalmol. 2011;249(10):1511. doi:10.1007/s00417-011-1803-9

5. Ursea R, Feng MT, Zhou M, Lien V, Loeb R. Pain perception in sequential cataract surgery: Comparison of first and second procedures. Journal of Cataract & Refractive Surgery. 2011;37(6):1009-1014. doi:10.1016/j.jcrs.2011.01.020

6. Hari-Kovacs A, Lovas P, Facsko A, Crate ID. Is second eye phacoemulsification really more painful? Wien Klin Wochenschr. 2012;124(15-16):516-519. doi:10.1007/s00508-012-0205-2