Descemet Endothelial Thickness Comparison Trial I

Fuchs Clinical Trial

— DETECT I  

Official title:

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289661
• Other study ID #: 20220590-I
• Status: Recruiting
• Phase: Phase 3
• Start date: July 15, 2022
• Est. completion date: March 31, 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
• Study type: Interventional

Clinical Trial Summary

Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata

• Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfuction such as Posterior Polymorphous Corneal Dystrophy (PPMD)

• Dysfunctional endothelium from prior graft failure after PKP or EK

• Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis

• Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg) or no glaucoma

• Good candidate for corneal transplantation for either DMEK or UT-DSAEK

• 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:

• Aphakia, or 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

• Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours

• Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology

• Inability to comply with post-operative instructions (i.e. unable to position)

• Pregnancy

• Cataract surgery within the last 3 months

• Fellow eye visual acuity <20/200

Related Conditions & MeSH terms

• Fuchs

Intervention

Drug:
• Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
• Topical 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	12 months
Primary	Endothelial cell loss	Change between endothelial density at baseline versus density at 12 months	12 months
Secondary	Best spectacle-corrected visual acuity (BSCVA)	Best spectacle-corrected visual acuity	3, 6 and 24 months