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NCT04175938 | RECRUITING | Fuchs' Endothelial Corneal Dystrophy

Assessment of Corneal Endothelial Function Following Hypoxic Stress
Sponsor:

Massachusetts Eye and Ear Infirmary

Information provided by (Responsible Party):

Ula jurkunas

Brief 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.

Condition or disease

Fuchs' Endothelial Corneal Dystrophy

Intervention/treatment

Wearing of contact lens

Phase

PHASE1

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Assessment of Corneal Endothelial Function Following Hypoxic Stress
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2027-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
    • -
Assessment of Corneal Endothelial Function Following Hypoxic Stress

Location Details

NCT04175938

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114