Authorised Therapeutic use (Phase IV) Fuchs dystrophy

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).

EU CTIS ID: 2023-510091-31-00

What this study is testing

Compare central macular thickness and the risk of cystoid macular edema between two medication regimens after corneal endothelial transplantation

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

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 informed consent form (ICF) and in this protocol.

You likely can't join if

  • • Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding) o Pregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5
  • • 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.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.