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

NCT ID: NCT05072262

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2026-10-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (dexamethasone only)

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Group Type: ACTIVE_COMPARATOR

Dexamethasone Ophthalmic

Intervention Type: DRUG

Topical dexamethasone 1 mg/ml (Spersadex)

Study group (NSAIDs and dexamethasone)

Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.

Group Type: EXPERIMENTAL

Nepafenac Ophthalmic

Intervention Type: DRUG

Topical nepafenac (Nevanac) 3 mg/ml

Dexamethasone Ophthalmic

Intervention Type: DRUG

Topical dexamethasone 1 mg/ml (Spersadex)

Interventions

Nepafenac Ophthalmic

Topical nepafenac (Nevanac) 3 mg/ml

Intervention Type: DRUG

Dexamethasone Ophthalmic

Topical dexamethasone 1 mg/ml (Spersadex)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olav Kristianslund

Principal investigator, Senior consultant MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olav Kristianslund, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Oslo University Hospital

Locations

Department of Ophthalmology, Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Olav Kristianslund, MD PhD

Role: CONTACT

olakri@ous-hf.no

+4722118545

Facility Contacts

Olav Kristianslund, PhD

Role: primary

Other Identifiers

2020-003408-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

131128

Identifier Type: -

Identifier Source: org_study_id