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New treatment option for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Official title DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
ClinicalTrials.gov ID: NCT05072262
What this study is testing
What is Nepafenac Ophthalmic?
Nepafenac Ophthalmic is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for descemet stripping automated endothelial keratoplasty (dsaek).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.