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Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
NCT03813056 · View on ClinicalTrials.gov ↗
Study Summary
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal. The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.
Conditions Studied
Interventions
- DRUG Glanatec
- DRUG Optive, Ophthalmic Solution
- PROCEDURE Descemet Membrane Endothelial Keratoplasty
Study Locations (1)
Oregon
- Devers Eye Institute — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2025-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03813056
The ClinicalTrials.gov registry entry for NCT03813056 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael D. Straiko, MD, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fuchs Endothelial Dystrophy appearing as the primary indexed condition, and to 3 interventions — of which Glanatec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03813056 reports 1 study location spanning 1 distinct geographic area — top geographies include Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03813056 about?
NCT03813056 is a clinical study titled "Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy". Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solut...
What is the current status of trial NCT03813056?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2019-03-25. Estimated completion is 2025-02-01.
What conditions does trial NCT03813056 study?
This clinical trial studies the following conditions: Fuchs Endothelial Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03813056?
The interventions under investigation include: Glanatec (DRUG), Optive, Ophthalmic Solution (DRUG), Descemet Membrane Endothelial Keratoplasty (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03813056?
This trial is sponsored by Michael D. Straiko, MD, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03813056 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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