Descemet Endothelial Thickness Comparison Trial II

Study Overview
=================
Brief Summary
-----------------
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

Official Title
-----------------
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Conditions
-----------------
Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

Intervention / Treatment
-----------------
* Drug: Ripasudil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm Peripheral endothelial cell count >1500 cells/mm2 Good surgical candidate for either procedure as determined by the surgeon 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: Other primary endothelial dysfunction such as PPMD Any prior intraocular surgery other than cataract surgery Cataract surgery within the last 3 months >3 clock hours of ANY anterior or posterior synechiae >1 quadrant of stromal corneal vascularization Visually significant optic nerve or macular pathology Fellow eye visual acuity <20/200 Pregnancy Inability to comply with post-operative instructions (i.e. unable to position) Hypotony (Intraocular pressure <10mmHg) Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours Aphakia, 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: DMEK plus topical placebo<br> | Drug: Placebo<br>* Topical Placebo<br>|
| Experimental: DSO plus topical ripasudil 0.4%<br> | Drug: Ripasudil<br>* Topical Ripasudil 0.4%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle-corrected visual acuity (BSCVA) | Best spectacle-corrected visual acuity (BSCVA) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle-corrected visual acuity (BSCVA) | Best spectacle-corrected visual acuity (BSCVA) | 3, 6 and 24 months | 
| Endothelial cell density | Endothelial cell density | 3, 6, and 24 months |