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NCT Number: NCT05072262

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

Location status: Recruiting

Location contact

Olav Kristianslund, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nepafenac Ophthalmic

Drug

Topical nepafenac (Nevanac) 3 mg/ml

Dexamethasone Ophthalmic

Drug

Topical dexamethasone 1 mg/ml (Spersadex)

Primary outcomes

  1. Central macular thickness after 4 weeks

    Time frame: 4 weeks after surgery

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

  2. Cystoid macular edema (CME) after 4 weeks

    Time frame: 4 weeks after surgery

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

Secondary outcomes

  1. Intraocular inflammation

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

    Measured by laser flare meter

  2. Intraocular pressure

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

    Measured by tonometry

  3. Visual outcome

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

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  4. Corneal endothelial status

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

    Measure corneal endothelial cell density using microscopy instrument

  5. Patient reported outcome measure (PROM)

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

    COMToL questionnaire for ocular medication

  6. Central macular thickness (CMT)

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

    Measure CMT (in um) on optical coherence tomography (OCT)

  7. Cystoid macular edema (CME)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Olav Kristianslund, MD PhD

CONTACT

[email protected]

+4722118545

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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)

Acronym: DMEC

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 8, 2021
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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