RecruitingPhase 3NCT05275972

Descemet Endothelial Thickness Comparison Trial II

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)


Sponsor

Stanford University

Enrollment

60 participants

Start Date

Jan 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for corneal transplantation in patients with Fuchs' Endothelial Corneal Dystrophy (FECD), a disease where the inner layer of the cornea degrades over time, causing blurred vision. Researchers want to find out which type of transplant leads to better vision and faster recovery. You may be eligible if: - You are 18 years or older - You have FECD with guttata (bumps on the cornea) extending beyond 4.5 mm - Your peripheral endothelial cell count is over 1000 cells/mm² in at least one quadrant - You are considered a good surgical candidate by the surgeon You may NOT be eligible if: - You have significant scarring in the central cornea affecting vision - You have another primary corneal endothelial condition (e.g., PPMD) - You have significant optic nerve or macular disease - You have low eye pressure (below 10 mmHg) - You have had any prior eye surgery other than cataract surgery - You have extensive synechiae (adhesions inside the eye) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRipasudil

Topical Ripasudil 0.4%

DRUGPlacebo

Topical Placebo


Locations(8)

Stanford University

Palo Alto, California, United States

University of California Davis

Sacramento, California, United States

University of Miami

Palm Beach Gardens, Florida, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Legacy Devers Eye Institute

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05275972


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