OCT in Fuchs' Dystrophy

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.

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Key information

Conditions

Fuchs Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Pseudophakic Bullous Keratopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

National Eye Institute (NEI)

Registry information

Official study title

Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2028
First posted: Feb 6, 2020
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting