WithdrawnPhase 1/2

Assessment of Corneal Endothelial Function Following Hypoxic Stress

Stopped: Awaiting transfer of study oversight from MEEI to Partners Healthcare

United States0Started 2025-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Thickness of the cornea before and after the stress test

Timeframe: seven hours

The rate of corneal recovery after the stress test

Timeframe: three hours

Time to full recovery from swelling

Timeframe: three hours

Trial details

NCT IDNCT04175938

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Fuchs' Endothelial Corneal Dystrophy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.