Descemet Endothelial Thickness Comparison Trial I

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05289661

Acronym

DETECT I

Enrollment

160

Registered

2022-03-21

Start date

2022-07-15

Completion date

2027-11-30

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs

Brief 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.

Interventions

DRUGTopical Ripasudil

To determine the effect of rho-kinase inhibitors on endothelial cell loss

DRUGTopical Placebo

topical Placebo

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Best spectacle-corrected visual acuity (BSCVA)	12 months	Best spectacle-corrected visual acuity
Endothelial cell loss	12 months	Change between endothelial density at baseline versus density at 12 months

Secondary

Measure	Time frame	Description
Best spectacle-corrected visual acuity (BSCVA)	3, 6 and 24 months	Best spectacle-corrected visual acuity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026