Using OCT to assess corneal health in Fuchs' Dystrophy
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
This study is testing a new way to measure corneal swelling in people with Fuchs' dystrophy to see how it affects their vision after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT04258787 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes optical coherence tomography (OCT) technology to measure corneal edema in patients with Fuchs' endothelial dystrophy and pseudophakic bullous keratopathy. The goal is to quantify the extent of corneal swelling and predict changes in vision following surgical interventions. Participants will undergo regular study visits to monitor their condition and the effects of treatment. The study aims to enhance understanding of corneal health in these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals with damaged or diseased corneal endothelium due to Fuchs' dystrophy or pseudophakic bullous keratopathy who can commit to study visits.
Not a fit: Patients who have undergone prior endothelial keratoplasty or have other significant ocular conditions that may complicate treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment outcomes for patients with Fuchs' dystrophy and related conditions.
How similar studies have performed: While the use of OCT in corneal assessments is established, this specific application in Fuchs' dystrophy and pseudophakic bullous keratopathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Damaged or diseased corneal endothelium from Fuchs' or PBK * Willingness to commit to required study visits Exclusion Criteria: * Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery * Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis) * Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome) * Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment * Peripheral anterior synechiae in the angle greater than 3 clock hours * Hypotony * Uncontrolled glaucoma * Visually significant optic nerve or macular pathology
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Winston Chamberlain, MD, PhD — Oregon Health and Science University
- Study coordinator: Humberto Martinez, COT
- Email: martinhu@ohsu.edu
- Phone: 503-494-7712
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.