A Phase 1/2 interventional study of Wearing of contact lens in Fuchs' Endothelial Corneal Dystrophy, sponsored by Massachusetts Eye and Ear Infirmary. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Massachusetts Eye and Ear Infirmary · Phase 1/2, Interventional, and Health services research
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.
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
Browse Fuchs' Endothelial Dystrophy studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Inclusion Criteria:
Subjects in the Fuch's Dystrophy arm of the study must meet following criteria:
Subjects in the healthy eyes arm of the study must meet following criteria:
Exclusion Criteria: Pregnant women
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Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.
Device: Wearing of contact lens
Persons with healthy eyes will wear a contact lens in one eye for three hours.
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.
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
Time frame: seven hours
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
Time frame: three hours
Time to full recovery from swelling
The time it takes for the eye to no longer be swollen
Time frame: three hours
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →
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