Assessment of Corneal Endothelial Function Following Hypoxic Stress

Fuchs' Endothelial Corneal Dystrophy Clinical Trial

Official title:

Assessment of Corneal Endothelial Function Following Hypoxic Stress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04175938
• Other study ID #: 2019P002073
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Stacey M Ellender, PhD
• Phone: 617-573-5507
• Email: stacey_ellender[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria: Pregnant women

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Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Fuchs' Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Device:
• Wearing of contact lens
All subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

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