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)
Who is this study for? Patients with Eye Diseases
What treatments are being studied? Dexamethasone Ophthalmic
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Norway
Department of Ophthalmology, Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Olav Kristianslund, MD PhD
olakri@ous-hf.no
+4722118545
Time Frame
Start Date: 2022-11-25
Estimated Completion Date: 2026-10
Participants
Target number of participants: 300
Treatments
Active_comparator: Control (dexamethasone only)
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
Experimental: Study group (NSAIDs and dexamethasone)
Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital