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Clinical Trial Summary

The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.


Clinical Trial Description

Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD. Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04175938
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact Stacey M Ellender, PhD
Phone 617-573-5507
Email stacey_ellender@meei.harvard.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date December 2024
Completion date November 30, 2026

See also
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Completed NCT05531760 - Predictive Factors of Graft Detachment Following Dmek
Completed NCT04250207 - Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis Phase 2
Completed NCT00800111 - Study of Endothelial Keratoplasty Outcomes N/A