Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2023-01-23
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DMEK plus topical placebo
Placebo
Topical Placebo
DSO plus topical ripasudil 0.4%
Ripasudil
Topical Ripasudil 0.4%
Interventions
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Ripasudil
Topical Ripasudil 0.4%
Placebo
Topical Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 position)
* Pregnancy
18 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
University of California, San Francisco
OTHER
University of California, Davis
OTHER
Case Western Reserve University
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
University of Pennsylvania
OTHER
University of Miami
OTHER
Wills Eye Hospital
UNKNOWN
Stanford University
OTHER
Responsible Party
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Jennifer Rose-Nussbaumer
Associate Professor
Principal Investigators
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Jennifer Rose-Nussbaumer, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of Miami
Palm Beach Gardens, Florida, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Nicole Varnado, MPH
Role: primary
Denise Macias
Role: primary
Ryan Stanfield
Role: primary
Patrick Herrin
Role: primary
Kenia Chavez
Role: primary
Emma Iacobucci
Role: primary
Alice Drew
Role: primary
References
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Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy. BMJ Open Ophthalmol. 2024 Oct 1;9(1):e001725. doi: 10.1136/bmjophth-2024-001725.
Other Identifiers
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20220590-II
Identifier Type: -
Identifier Source: org_study_id