DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nepafenac Ophthalmic
  • Dexamethasone Ophthalmic

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators