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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	25.11.2022

Trial locations

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.

Investigated diseases:

Corneal dystrophy

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 ID:

2023-510091-31-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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