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

• Conditions: Endothelial Cell Density Loss
• Interventions: Diagnostic Test: Imaging

• Registration Number: NCT04882189
• Lead Sponsor: Centricity Vision, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Study Start: 2021-08-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-03-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ZEPTO Precision Capsulotomy Device	Imaging	Capsulotomies conducted by ZEPTO Precision Capsulotomy Device
Capsulorhexis	Imaging	Capsulotomies conducted by Capsulorhexis

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Density Loss	3 months	Post Cataract Surgery

Secondary Outcome Measures

Name	Time	Method
% of hexagonal cells	1 and 3 months	Post Cataract Surgery
Endothelial Cell Density Loss	1 month	Post Cataract Surgery
Coefficient of Variation in Endothelial Cell Size	1 and 3 months	Post Cataract Surgery

Trial Locations

Locations (2)

UltraVision; 🇺🇸 San Antonio, Texas, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States