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Active Not RecruitingNCT05289661

Descemet Endothelial Thickness Comparison Trial I

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
160 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTopical RipasudilTo determine the effect of rho-kinase inhibitors on endothelial cell loss
DRUGTopical Placebotopical Placebo

Timeline

Start date
2022-07-15
Primary completion
2026-11-30
Completion
2027-11-30
First posted
2022-03-21
Last updated
2025-12-17

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05289661. Inclusion in this directory is not an endorsement.