OCT in Fuchs' Dystrophy NCT04258787

Updated 05/28/2024

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT04258787
Other study ID #	OHSU IRB#00020108
Secondary ID	R01EY029023-01
Status	Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT04527523` - Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only
	Completed	`NCT03763721` - The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation	N/A
	Recruiting	`NCT04191629` - Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema	Phase 1
	Recruiting	`NCT05853978` - The Evaluation of Balanced Salt Solution During Cataract Surgery	Phase 4
	Recruiting	`NCT03575130` - Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy	Phase 2
	Active, not recruiting	`NCT04894110` - Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema	Phase 1
	Completed	`NCT00346138` - A Comparison Between Full Thickness and Partial Thickness Corneal Transplantation for Corneal Edema	N/A
	Recruiting	`NCT05275972` - Descemet Endothelial Thickness Comparison Trial II	Phase 3
	Active, not recruiting	`NCT04564378` - Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
	Completed	`NCT04676737` - TTHX1114(NM141) in Combination With DWEK/DSO	Phase 2
	Recruiting	`NCT03619434` - Femtolaser Assisted Keratoplasty Versus Conventional Keratoplasty	N/A
	Recruiting	`NCT05636579` - Study to Assess Safety and Tolerability of Multiple Doses of EO2002	Phase 1