Assessing corneal function after contact lens use in Fuchs' dystrophy patients
Assessment of Corneal Endothelial Function Following Hypoxic Stress
PHASE1; PHASE2 · Massachusetts Eye and Ear Infirmary · NCT04175938
This study is testing how contact lenses affect the corneas of people with Fuchs' dystrophy compared to healthy individuals to see if it can help identify those at risk for corneal swelling.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04175938 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the corneal response to contact lens placement in patients with Fuchs' endothelial corneal dystrophy (FECD) compared to healthy individuals. By measuring corneal swelling and recovery after a stress test involving FDA-approved contact lenses, researchers hope to establish a method for assessing endothelial cell function. The study will involve both patients diagnosed with FECD who are scheduled for corneal transplantation and healthy participants without ocular disease. The findings could lead to better identification of patients at risk for corneal swelling.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Fuchs' endothelial corneal dystrophy who are scheduled for corneal transplantation within the next six months.
Not a fit: Patients who have undergone prior ocular surgery or have a history of contact lens intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new tool for assessing corneal health and risk in patients with Fuchs' dystrophy, potentially improving patient management and outcomes.
How similar studies have performed: While there is limited data on similar approaches, the study aims to pioneer a direct measurement method for endothelial function in FECD patients.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Stacey M Ellender, PhD
- Email: stacey_ellender@meei.harvard.edu
- Phone: 617-573-5507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fuchs' Endothelial Corneal Dystrophy, Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy