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

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nepafenac Ophthalmic

    Drug

    Topical nepafenac (Nevanac) 3 mg/ml

  • Dexamethasone Ophthalmic

    Drug

    Topical dexamethasone 1 mg/ml (Spersadex)

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Control (dexamethasone only)Active comparator 1 intervention
Group B: Study group (NSAIDs and dexamethasone)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Central macular thickness after 4 weeks

Measure central macular thickness (in um) on optical coherence tomography (OCT)

Time frame
4 weeks after surgery
2

Cystoid macular edema (CME) after 4 weeks

Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Time frame
4 weeks after surgery

Secondary outcomes

1

Intraocular inflammation

Measured by laser flare meter

Time frame
Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
2

Intraocular pressure

Measured by tonometry

Time frame
Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
3

Visual outcome

Measure uncorrected and corrected distance visual acuity using visual acuity chart

Time frame
Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
4

Corneal endothelial status

Measure corneal endothelial cell density using microscopy instrument

Time frame
1 week, 4 weeks, 2 months and 2 years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Source ClinicalTrials.gov
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