Endothelial Cell Density Loss
Conditions
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.
Interventions
DIAGNOSTIC_TESTImaging
Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.
Sponsors
Centricity Vision, Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Cell Density Loss | 3 months | Post Cataract Surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Cell Density Loss | 1 month | Post Cataract Surgery |
| Coefficient of Variation in Endothelial Cell Size | 1 and 3 months | Post Cataract Surgery |
| % of hexagonal cells | 1 and 3 months | Post Cataract Surgery |
Countries
United States
Outcome results
None listed