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

NCT05072262 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-12-01

No results posted yet for this study

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).

Conditions

  • Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
  • Descemet Membrane Endothelial Keratoplasty (DMEK)

Interventions

DRUG

Nepafenac Ophthalmic

Topical nepafenac (Nevanac) 3 mg/ml

DRUG

Dexamethasone Ophthalmic

Topical dexamethasone 1 mg/ml (Spersadex)

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Olav Kristianslund, MD PhD · Department of Ophthalmology, Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-25
Primary Completion
2024-06-30
Completion
2026-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05072262 on ClinicalTrials.gov