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 range18 Years

SexALL

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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 \-

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