Recruiting NCT04258787
OCT in Fuchs' Dystrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fuchs Dystrophy, Pseudophakic Bullous Keratopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
Overview
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.
Primary outcome measures
- Corneal Epithelial Edema/Haze [Time frame: up to 2 years]
- Corneal Stromal Edema/Haze [Time frame: up to 2 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT04258787 · OHSU IRB#00020108 · R01EY029023-01