OCT in Fuchs' Dystrophy

Fuchs Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04258787
• Other study ID #: OHSU IRB#00020108
• Secondary ID: R01EY029023-01
• Status: Recruiting
• Start date: June 26, 2020
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Humberto Martinez, COT
• Phone: 503-494-7712
• Email: martinhu[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Epithelial Edema/Haze	OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK	up to 2 years
Primary	Corneal Stromal Edema/Haze	OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK	up to 2 years