Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO

Study Overview
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Brief Summary
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This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.

Official Title
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A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System

Conditions
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Endothelial Cell Density Loss

Intervention / Treatment
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* Diagnostic Test: Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study, Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months. Exclusion Criteria: Pre-existing corneal endothelium pathology Presence of guttae Narrow angle glaucoma or advanced glaucoma Psuedoexfoliation Zonular abnormalities Corneal endothelial cell density less than 1800 cells/mm2 Uveitis Anterior chamber depth less than 2.5mm or greater than 3.75mm Cataract grade LOCS II > 3 Posterior polar cataract Planned implantation of IOL > 25D Prior ocular surgery in the study eye History of medications with potential corneal endothelial cell toxicity Any condition that in the surgeon's judgement should exclude the subject from study enrollment. Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Capsulorhexis<br>Capsulotomies conducted by Capsulorhexis | Diagnostic Test: Imaging<br>* Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.<br>|
| ZEPTO Precision Capsulotomy Device<br>Capsulotomies conducted by ZEPTO Precision Capsulotomy Device | Diagnostic Test: Imaging<br>* Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Density Loss | Post Cataract Surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Density Loss | Post Cataract Surgery | 1 month | 
| Coefficient of Variation in Endothelial Cell Size | Post Cataract Surgery | 1 and 3 months | 
| % of hexagonal cells | Post Cataract Surgery | 1 and 3 months |