Descemet Endothelial Thickness Comparison Trial I (DETECT I)

Stanford University

Status and phase: Active, not recruiting; Phase 3

Conditions: Fuchs

Treatments: Drug: Topical Ripasudil; Drug: Topical Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05289661

20220590-I

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 dysfunction 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 to participate
• 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
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

160 participants in 4 patient groups, including a placebo group

UT-DSAEK plus topical ripasudil

Experimental group

Description:

This arm will receive UT-DSAEK plus topical ripasudil 0.4%

Treatment:

Drug: Topical Ripasudil

UT-DSAEK plus topical placebo

Placebo Comparator group

Description:

This arm will receive UT-DSAEK plus topical placebo

Treatment:

Drug: Topical Placebo

DMEK plus topical ripasudil

Experimental group

Description:

This arm will receive DMEK plus topical ripasudil 0.4%

Treatment:

Drug: Topical Ripasudil

DMEK plus topical placebo

Placebo Comparator group

Description:

This arm will receive DMEK plus topical placebo

Treatment:

Drug: Topical Placebo