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

Centricity Vision

Status

Unknown

Conditions

Endothelial Cell Density Loss

Treatments

Diagnostic Test: Imaging

Study type

Observational

Funder types

Industry

Identifiers

NCT04882189

13803

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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