Assessment of Corneal Endothelial Function Following Hypoxic Stress

Who is this study for? Patients with Fuchs endothelial corneal dystrophy scheduled for corneal transplantation in the next 6 months
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Massachusetts
Massachusetts Eye and Ear Infirmary
RECRUITING
Boston
Contact Information
Primary
Michael Cheung, MSc, CCRP
mcheung0@meei.harvard.edu
6175736060
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 20
Treatments
Active_comparator: Subjects with Fuch's Endothelial Dystrophy
Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.
Other: Subjects with healthy eyes
Persons with healthy eyes will wear a contact lens in one eye for three hours.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov