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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05275972
Other study ID # 20220590-II
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 23, 2023
Est. completion date November 30, 2027

Study information

Verified date May 2024
Source Stanford University
Contact Nicole Varnado, MPH
Phone 650-725-1688
Email nvarnado@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2027
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm - Peripheral endothelial cell count >1500 cells/mm2 - Good surgical candidate for either procedure as determined by the surgeon - Willingness and ability to undergo corneal transplantation - Willingness to consistently use study medications (i.e. ROCK-inhibitors) - Willingness to participate in follow-up visits - Age greater than 18 years Exclusion Criteria: - Other primary endothelial dysfunction such as PPMD - Any prior intraocular surgery other than cataract surgery - Cataract surgery within the last 3 months - >3 clock hours of ANY anterior or posterior synechiae - >1 quadrant of stromal corneal vascularization - Visually significant optic nerve or macular pathology - Fellow eye visual acuity <20/200 - Pregnancy - Inability to comply with post-operative instructions (i.e. unable to position) - Hypotony (Intraocular pressure <10mmHg) - Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours - Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK - Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ripasudil
Topical Ripasudil 0.4%
Placebo
Topical Placebo

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States University of Miami Palm Beach Gardens Florida
United States Stanford University Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Wills Eye Hospital Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States University of California Davis Sacramento California

Sponsors (7)

Lead Sponsor Collaborator
Stanford University Case Western Reserve University, Dartmouth-Hitchcock Medical Center, Oregon Health and Science University, University of California, Davis, University of California, San Francisco, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best spectacle-corrected visual acuity (BSCVA) Best spectacle-corrected visual acuity (BSCVA) 12 months
Secondary Best spectacle-corrected visual acuity (BSCVA) Best spectacle-corrected visual acuity (BSCVA) 3, 6 and 24 months
Secondary Endothelial cell density Endothelial cell density 3, 6, and 24 months
See also
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Completed NCT04420429 - The Effect Of Preoperative Parameters On Success After DMEK Surgery