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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| University of California, San Francisco | OTHER |
| University of California, Davis | OTHER |
| Case Western Reserve University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UT-DSAEK plus topical ripasudil | Experimental | This arm will receive UT-DSAEK plus topical ripasudil 0.4% |
|
| UT-DSAEK plus topical placebo | Placebo Comparator | This arm will receive UT-DSAEK plus topical placebo |
|
| DMEK plus topical ripasudil | Experimental | This arm will receive DMEK plus topical ripasudil 0.4% |
|
| DMEK plus topical placebo | Placebo Comparator | This arm will receive DMEK plus topical placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Ripasudil | Drug | To determine the effect of rho-kinase inhibitors on endothelial cell loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best spectacle-corrected visual acuity (BSCVA) | Best spectacle-corrected visual acuity | 12 months |
| Endothelial cell loss | Change between endothelial density at baseline versus density at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best spectacle-corrected visual acuity (BSCVA) | Best spectacle-corrected visual acuity | 3, 6 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Rose-Nussbaumer, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94303 | United States | ||
| University of California Davis |
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| ID | Term |
|---|---|
| C584679 | K-115 |
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| OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| University of Pennsylvania | OTHER |
| University of Miami | OTHER |
| Wills Eye Hospital | UNKNOWN |
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|
| Topical Placebo | Drug | topical Placebo |
|
|
| Sacramento |
| California |
| 95817 |
| United States |
| University of Miami | Palm Beach Gardens | Florida | 33418 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |