NCT05072262 DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
| NCT ID | NCT05072262 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oslo University Hospital |
| Condition | Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-11-25 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2022-11-25 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The DMEC trial is 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 (DSAEK or DMEK).
Eligibility 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)
Contact & Investigator
Olav Kristianslund, MD PhD
PRINCIPAL INVESTIGATOR
Department of Ophthalmology, Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05072262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Descemet Stripping Automated Endothelial Keratoplasty (DSAEK). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05072262 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05072262 currently recruiting?
Yes, NCT05072262 is actively recruiting participants. Contact the research team at olakri@ous-hf.no for enrollment information.
Where is the NCT05072262 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05072262 clinical trial?
NCT05072262 is sponsored by Oslo University Hospital. The principal investigator is Olav Kristianslund, MD PhD at Department of Ophthalmology, Oslo University Hospital. The trial plans to enroll 300 participants.