Assessment of Corneal Endothelial Function Following Hypoxic Stress

Phase 1

Recruiting

• Conditions: Fuchs' Endothelial Corneal Dystrophy
• Interventions: Device: Wearing of contact lens

• Registration Number: NCT04175938
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Study Start: 2024-12
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects in the Fuch's Dystrophy arm of the study must meet following criteria:

• Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
• Be scheduled for corneal transplantation in the next 6 months
• Have no history of prior ocular surgery in study eye
• Have no history of contact lens intolerance
• Be motivated and willing to complete ocular imaging tests

Subjects in the healthy eyes arm of the study must meet following criteria:

• Have no prior history of ocular disease including ocular surface disease or glaucoma
• Have no history of prior ocular surgery in study eye
• Have no history of contact lens intolerance
• Be motivated and willing to complete ocular imaging tests

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Exclusion Criteria

Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with healthy eyes	Wearing of contact lens	Persons with healthy eyes will wear a contact lens in one eye for three hours.
Subjects with Fuch's Endothelial Dystrophy	Wearing of contact lens	Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.

Primary Outcome Measures

Name	Time	Method
Time to full recovery from swelling	three hours	The time it takes for the eye to no longer be swollen
Thickness of the cornea before and after the stress test	seven hours	Maximum changes in the thickness of the cornea measured before and after the stress test
The rate of corneal recovery after the stress test	three hours	The extent of swelling evident at regular intervals during the 3 hours after the stress test

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States