OCT in Fuchs' Dystrophy
Part of paid clinical trials in Portland, Oregon.
- Sponsor
- Oregon Health and Science University
- Study ID
- NCT04258787
- Status
- Recruiting
Conditions
- Fuchs Dystrophy
- Pseudophakic Bullous Keratopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Jun 26, 2020
- Status verified
- Sep 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Group A: No Surgery GroupThis group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy but do not require surgery per standard-of-care guidelines.
- Arm: Group B: Surgery GroupThis group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy, who require Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery. All treatment decisions will be made by the attending physician based on standard-of-care guidelines. (The study does not designate a treatment modality or pay for the treatment.)
Primary Outcome Measure
Corneal Epithelial Edema/Haze [ Time Frame: up to 2 years ]
Central Contacts
- Humberto Martinez, COT503-494-7712
- Denzil Romfh, OD503-494-4351
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | David Huang, MD, PhD (SUB_INVESTIGATOR) Afshan Nanji, MD (SUB_INVESTIGATOR) Richard Stutzman, MD (SUB_INVESTIGATOR) Yan Li, PhD (SUB_INVESTIGATOR) |
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