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Descemet Membrane Endothelial Keratoplasty for Fuchs' Dystrophy

Phase 2
Recruiting
Led By Michael D Straiko, M.D.
Research Sponsored by Michael D. Straiko, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing whether a standard DMEK surgery in combination with Ripasudil treatment can help patients with Fuchs Endothelial Corneal Dystrophy by accelerating endothelial cell healing and clearing edematous corneas faster.

Who is the study for?
This trial is for people with Fuchs' Dystrophy, specifically grades 2-5 on the Krachmer scale. Participants must have decreased vision primarily due to central guttae or stromal edema and a visual acuity of 20/40 or worse. They can be phakic or pseudophakic with certain types of lens implants.Check my eligibility
What is being tested?
The study tests Ripasudil (Glanatec ophthalmic solution) used after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery in Fuchs' Dystrophy patients. The aim is to see if it speeds up corneal clearing and reduces post-op complications compared to standard treatment.See study design
What are the potential side effects?
Ripasudil may cause side effects like eye irritation, redness, discomfort, or changes in intraocular pressure since it's also used for glaucoma by affecting fluid outflow in the eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to corneal clearance
Secondary outcome measures
Best corrected visual acuity
Endothelial cell density
Post surgery complications

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GlanatecExperimental Treatment2 Interventions
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Group II: Placebo ControlPlacebo Group2 Interventions
Optive artificial tears will be administered 6x per day for 2-4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Descemet Membrane Endothelial Keratoplasty
2014
N/A
~240

Find a Location

Who is running the clinical trial?

Eye Bank Association of AmericaOTHER
1 Previous Clinical Trials
1,090 Total Patients Enrolled
1 Trials studying Fuchs' Dystrophy
1,090 Patients Enrolled for Fuchs' Dystrophy
Lions VisionGift ResearchOTHER
1 Previous Clinical Trials
50 Total Patients Enrolled
Michael D. Straiko, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left for individuals to join this trial?

"Affirmative, clinicaltrials.gov records demonstrate that this medical experiment is currently enrolling patients. This trial was initially listed on March 25th 2019 and recently updated on September 2nd 2021. The research team seeks to recruit 72 participants at a single site."

Answered by AI

What medical condition is Descemet Membrane Endothelial Keratoplasty employed to manage?

"Descemet Membrane Endothelial Keratoplasty is a curative approach for glaucoma and its suspected subtypes, such as Open Angle Glaucoma (OAG)."

Answered by AI

How many study participants are receiving treatment as part of this investigation?

"Affirmative. Evidence on clinicaltrials.gov supports that recruitment for this research project, which was inaugurated on March 25th 2019, is still ongoing. 72 participants are needed from a single medical centre."

Answered by AI

Has the FDA cleared Descemet Membrane Endothelial Keratoplasty for clinical use?

"Our team at Power has deemed Descemet Membrane Endothelial Keratoplasty to be a 2 on the safety scale, as this procedure is currently in its second phase of testing - meaning there are preliminary data supporting its security but none yet affirming effectiveness."

Answered by AI

Is the age threshold for this research project set at twenty or higher?

"This clinical trial requires that participants must be between 30 and 99 years old. For those below 18 or above 65, there are 1 and 13 corresponding trials respectively."

Answered by AI

Who would be a suitable participant in this research investigation?

"In order to be admitted into this trial, patients should have a diagnosis of fuchs' endothelial dystrophy and must lie within the age bracket of 30-99 years old. 72 volunteers are needed in total."

Answered by AI

What other research initiatives have been undertaken related to Descemet Membrane Endothelial Keratoplasty?

"Currently, two trials are underway that assess the efficacy of Descemet Membrane Endothelial Keratoplasty; however, neither is in Phase 3. Despite this limitation, 4 hospitals located in Kitakyushu and Fukuoka are running investigations into this form of therapy."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
Michael D. Straiko, MD 2019. "Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03813056.
~9 spots leftby Feb 2025
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