OCT in Fuchs' Dystrophy

Recruiting

• Conditions: Fuchs Dystrophy; Pseudophakic Bullous Keratopathy

• Registration Number: NCT04258787
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2020-06-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Stromal Edema/Haze	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	up to 2 years	OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States