Trials / Unknown
UnknownNCT04882189
Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO
A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (estimated)
- Sponsor
- Centricity Vision, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Imaging | Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery. |
Timeline
- Start date
- 2021-08-23
- Primary completion
- 2022-03-30
- Completion
- 2022-05-30
- First posted
- 2021-05-11
- Last updated
- 2022-03-22
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04882189. Inclusion in this directory is not an endorsement.