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Study on Nepafenac and Dexamethasone for Reducing Inflammation and Swelling in Fuchs Dystrophy Patients After Corneal Transplant

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two different medication regimens in patients undergoing a specific type of eye surgery called corneal endothelial transplantation, which is often needed for conditions like Fuchs' dystrophy. The study will compare the use of a combination of medications, specifically NEVANAC (which contains the active ingredient nepafenac) and Spersadex (which contains dexamethasone), against the use of only Spersadex after surgery. These medications are administered as eye drops.

The purpose of the study is to compare the effects of these medication regimens on eye inflammation and a condition called cystoid macular edema, which can affect vision. Participants in the study will be randomly assigned to one of the two treatment groups. The study will monitor changes in the thickness of the central part of the retina, known as the macula, and the presence of any fluid-filled cysts in this area. The study will also look at other factors such as eye pressure and visual clarity over a period of time.

Participants will receive either the combination of NEVANAC and Spersadex or only Spersadex for a set period after their surgery. The study aims to provide insights into which treatment regimen is more effective in managing inflammation and preventing cystoid macular edema following corneal endothelial transplantation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to sign an informed consent form. This document confirms your willingness to participate and your understanding of the trial's requirements and restrictions.

    You must be at least 18 years old and scheduled for a specific type of eye surgery known as DSAEK or DMEK. Your ability to cooperate during examinations is necessary.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, you will undergo a series of examinations to assess your eye condition. These tests are designed to ensure you meet the trial's criteria and to gather baseline data for comparison after the surgery.

  3. Step 3

    Surgery

    You will undergo corneal endothelial transplantation, which is a procedure to replace the damaged inner layer of your cornea. This step is crucial for the trial as it sets the stage for the medication regimen to be tested.

  4. Step 4

    Medication regimen

    After the surgery, you will be assigned to one of two groups. One group will receive a combination of nepafenac and dexamethasone eye drops, while the other group will receive only dexamethasone eye drops.

    Nepafenac is a non-steroidal anti-inflammatory drug (NSAID) used to reduce inflammation, and dexamethasone is a steroid used to prevent swelling. Both medications are administered as eye drops.

    The dosage and frequency of the eye drops will be determined by the trial protocol and will be explained to you by the medical staff.

  5. Step 5

    Follow-up visits

    You will have scheduled follow-up visits to monitor your recovery and the effects of the medication. These visits will include eye examinations to measure central macular thickness and check for any macular cysts.

    Additional assessments may include measuring intraocular pressure, visual acuity, and corneal endothelial cell density.

  6. Step 6

    Completion of trial

    The trial is expected to continue until October 2026. Your participation will contribute to understanding the effectiveness of the medication regimens in reducing inflammation and preventing cystoid macular edema after corneal transplantation.

Who can join the trial?

4 criteria

  • Patients must be 18 years and older at the time of signing the informed consent. There is no upper age limit.
  • Scheduled for DSAEK or DMEK surgery. These are types of eye surgeries to replace the inner layer of the cornea.
  • Ability to cooperate fairly well during the examinations.
  • Willing to participate in the study and capable of giving informed consent, which means understanding and agreeing to follow the study's requirements and restrictions.

Who cannot join the trial?

3 criteria

  • Patients with a condition called Fuchs dystrophy cannot participate.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • NSAIDs

    are a type of medication that helps reduce inflammation and pain. In this trial, they are used as eye drops after corneal endothelial transplantation to help decrease swelling and prevent complications like cystoid macular edema, which is a condition where fluid builds up in the eye, potentially affecting vision.

  • Steroids

    are medications that help reduce inflammation and suppress the immune system. In this trial, they are used as eye drops after corneal endothelial transplantation to help control inflammation and reduce the risk of developing cystoid macular edema, which can occur after eye surgery.

What is already known about the treatment

  • Postoperative Topical NSAIDs

    This medication is applied as eye drops after corneal endothelial transplantation to help reduce inflammation and prevent cystoid macular edema, a condition where fluid accumulates in the retina. It is currently being studied in clinical trials to compare its effectiveness against using only postoperative topical steroids. NSAIDs, or non-steroidal anti-inflammatory drugs, work by blocking certain enzymes in the body that cause inflammation, providing relief from swelling and pain. They are classified as anti-inflammatory agents and are commonly used to manage pain and inflammation in various medical conditions.

  • Postoperative Topical Steroids

    These eye drops are used after corneal endothelial transplantation to reduce inflammation and the risk of cystoid macular edema. They are being compared in clinical trials to a regimen that includes both NSAIDs and steroids. Steroids work by suppressing the immune system's response, thereby reducing inflammation and swelling. They belong to a class of drugs known as corticosteroids, which are widely used to treat a variety of inflammatory and autoimmune conditions.

Investigated diseases

Fuchs' Dystrophy – Fuchs' dystrophy is an eye disease that affects the cornea, the clear front surface of the eye. It is characterized by the gradual deterioration of the corneal endothelial cells, which are responsible for maintaining the proper amount of fluid in the cornea. As these cells deteriorate, fluid builds up in the cornea, causing it to swell and thicken. This leads to blurred vision, glare, and sensitivity to light, especially in the morning. Over time, the cornea may develop tiny blisters on its surface, which can burst and cause pain. The disease typically progresses slowly and can affect both eyes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510091-31-00Estimated enrolment120 patientsSponsorOslo University Hospital HF

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