Comparing medications for eye surgery recovery
A Randomized Clinical Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations (DMEC)
This study tests if adding a new eye medication to a common steroid can help people recover better after corneal surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05072262 on ClinicalTrials.gov |
What this trial studies
The DMEC trial is a randomized clinical trial that investigates the effects of postoperative topical non-steroidal anti-inflammatory drugs (NSAIDs) versus steroids alone in patients undergoing corneal endothelial transplants, specifically DSAEK or DMEK. The study aims to assess inflammation and the incidence of cystoid macular edema following these procedures. Participants will be randomly assigned to receive either a combination of Nepafenac and Dexamethasone or Dexamethasone alone. The trial seeks to determine if the addition of NSAIDs can improve postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for DSAEK or DMEK procedures.
Not a fit: Patients with contraindications to the medications, preoperative macular edema, or those undergoing re-transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and reduced complications for patients undergoing corneal transplantation.
How similar studies have performed: Other studies have shown promising results with the use of NSAIDs in postoperative care, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit. * Scheduled for DSAEK or DMEK * Ability to cooperate fairly well during the examinations * Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding) * Pregnancy or possible pregnancy during the study period * Preoperative macular edema and/or ongoing treatment for macular edema * Re-transplantation * In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve) * Aphakic eyes (eyes without a biological or artificial intraocular lens) * Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
Where this trial is running
Oslo
- Department of Ophthalmology, Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Olav Kristianslund, MD PhD — Department of Ophthalmology, Oslo University Hospital
- Study coordinator: Olav Kristianslund, MD PhD
- Email: olakri@ous-hf.no
- Phone: +4722118545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.