NCT04258787RecruitingNot Applicable
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
Oregon Health and Science University1 site in 1 country60 target enrollmentStarted: June 26, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Corneal Stromal Edema/Haze
Study Overview
Brief Summary
This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Uncontrolled glaucoma
- •Visually significant optic nerve or macular pathology
Outcomes
Primary Outcomes
Corneal Stromal Edema/Haze
Time Frame: up to 2 years
OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK
Corneal Epithelial Edema/Haze
Time Frame: up to 2 years
OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK
Secondary Outcomes
No secondary outcomes reported
Investigators
David Huang
Principal Investigator
Oregon Health and Science University
Study Sites (1)
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