NCT05275972 · Stanford University
Descemet Endothelial Thickness Comparison Trial II
(DETECT II)
What this study is about
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, compared against an inactive treatment clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.
View original scientific description
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.
Interventions
DRUG
Ripasudil
Topical Ripasudil 0.4%
DRUG
Placebo
Topical Placebo
Primary outcome measures
Best spectacle-corrected visual acuity (BSCVA)
Time frame: 12 months
Best spectacle-corrected visual acuity (BSCVA)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
- Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant
- Good surgical candidate for either procedure as determined by the surgeon
- Willingness to participate
- Age greater than 18 years
Exclusion criteria
- 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
- Other primary endothelial dysfunction such as PPMD
- Visually significant optic nerve or macular pathology
- Hypotony (Intraocular pressure \<10mmHg)
- Any prior intraocular surgery other than cataract surgery
- \>3 clock hours of ANY anterior or posterior synechiae
- \>1 quadrant of stromal corneal vascularization
- Inability to comply with post-operative instructions (i.e. unable to po
Where
- Palo Alto, California
- Sacramento, California
- Palm Beach Gardens, Florida
- Lebanon, New Hampshire
- Portland, Oregon
- Philadelphia, Pennsylvania
Collaborators
Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania, University of Miami, Wills Eye Hospital, Devers Eye Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations