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DMEK vs. DSO + Ripasudil for Fuchs' Dystrophy (DETECT II Trial)
DETECT II Trial Summary
This trial is testing two different treatments for Fuchs endothelial dystrophy, a disease of the eye. One treatment is Descemet Membrane Endothelial Keratoplasty (DMEK), while the other is Descemet Stripping Only (DSO) with adjunctive Ripasudil. 60 patients will be randomly assigned to one of these two treatments to see which is more effective.
DETECT II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDETECT II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DETECT II Trial Design
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Who is running the clinical trial?
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- I had cataract surgery in the last 3 months.My eye condition affects the inner layer of my cornea and has spread beyond 4.5 mm.I have had eye surgery, but it was not for cataracts.My eye pressure is lower than normal.I am willing and able to have a cornea transplant.My study eye has or will have a special lens due to missing natural lens.I have a condition affecting the inner lining of my blood vessels.I am willing to take the study medications as directed.I can follow post-surgery care instructions.I have a serious eye condition affecting my optic nerve or macula.My surgeon considers me a good candidate for surgery.I have blood vessels growing in more than one area of my cornea.I am older than 18 years.My eye has iris adhesion to the angle in more than 3 clock hours.I am willing to attend all follow-up appointments.My other eye's vision is worse than 20/200.
- Group 1: DSO plus topical ripasudil 0.4%
- Group 2: DMEK plus topical placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial also being conducted in other parts of Canada?
"The 4th and final location for this trial is still being decided, but the other three sites are at University of California Davis in Sacramento, Oregon Health & Science University in Portland, and Stanford University in Palo Alto."
What is the hard cap for patient recruitment in this experiment?
"That is correct. The clinicaltrials.gov website has information indicating that the trial is still recruiting patients. The trial was posted on 7/15/2022 and was updated on 8/23/2022. The study is seeking 60 participants from 4 locations."
Is this research project still looking for participants?
"This trial is currently recruiting participants, as noted on clinicaltrials.gov. The listing was originally posted on July 15, 2022, and last updated on August 23, 2022."
Are there any documented cases of serious harm caused by Ripasudil?
"There is some evidence of efficacy and numerous reports of Ripasudil's safety, so it was given a score of 3."
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