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Study on Dexamethasone and Fluorometholone for Patients Undergoing Corneal Transplantation

Fast replyRegistered 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 treatments for patients undergoing corneal transplantation, specifically a procedure known as Descemet's Membrane Endothelial Keratoplasty (DMEK). The study will evaluate two different eye drop medications: Dexamethasone and Fluorometholone. Dexamethasone is used in the form of a solution called "Dexamethason 1 mg/ml Teva, oogdruppels," while Fluorometholone is used as a suspension known as "FML Liquifilm 0.1% w/v Sterile Eye Drops Suspension."

The purpose of the study is to assess a treatment plan that aims to reduce the risk of increased eye pressure and loss of cells in the cornea after the DMEK procedure. Participants will be randomly assigned to receive either the Dexamethasone or Fluorometholone eye drops, or a placebo. The study will monitor the effects of these treatments over a period of up to two years, with regular check-ups to observe any changes in eye pressure and corneal health.

Throughout the study, researchers will also gather information on the overall health of the eye, including vision quality and patient satisfaction. The goal is to find the most effective way to support patients' recovery and maintain the health of the transplanted cornea. This trial will help determine the best approach to minimize complications and improve outcomes for individuals undergoing corneal 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.

Step 1
Joining the trial
Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your eligibility for the trial. This includes confirming that you are 21 years or older and registered as a candidate for Descemet's Membrane Endothelial Keratoplasty (DMEK) corneal transplantation.
Step 3
Medication administration
You will receive two types of eye drops: Dexamethason 1 mg/ml Teva and FML Liquifilm 0.1% w/v Sterile Eye Drops Suspension. These medications are applied topically to the corneal and limbal area of the eye.
The dosage and frequency of administration will be explained to you by the medical team. It is important to follow the instructions carefully to ensure the effectiveness of the treatment.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor your progress. During these visits, your eye pressure and the health of your cornea will be assessed.
The primary focus in the first year is to monitor for any increase in intraocular pressure (IOP), which is the pressure inside your eye. In the second year, the focus will shift to evaluating the loss of endothelial cells in your cornea.
Step 5
Outcome evaluation
The trial aims to assess various outcomes, including the survival of the corneal graft without rejection, your vision quality, and overall satisfaction with the treatment.
Economic evaluations will also be conducted to determine the cost-effectiveness of the treatment protocol.
Step 6
Completion of trial
The trial is expected to conclude by August 2028. Upon completion, the results will be analyzed to determine the effectiveness of the immunosuppressive protocol used in the study.

Who can join the trial?

3 criteria

Patients must be 21 years or older.
Patients must be registered on the NOTR (a registry for organ and tissue transplants) as candidates for Descemet's Membrane Endothelial Keratoplasty (DMEK), which is a type of corneal transplantation.
Both men and women can participate.

Who cannot join the trial?

7 criteria

Patients who have had a previous corneal transplant other than Descemet's Membrane Endothelial Keratoplasty (DMEK) cannot participate.
Patients with uncontrolled high eye pressure, known as intraocular pressure (IOP), are excluded. Intraocular pressure is the fluid pressure inside the eye.
Patients with severe eye infections or inflammation are not eligible.
Patients who are currently using medications that suppress the immune system, known as immunosuppressive drugs, for other conditions cannot join the study. Immunosuppressive drugs are medications that lower the body's ability to reject a transplanted organ.
Patients with a history of severe allergic reactions to medications used in the study are excluded.
Pregnant or breastfeeding women cannot participate in the trial.
Patients with other serious health conditions that could interfere with the study results are not eligible.

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Verified sites

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Academisch Ziekenhuis Leiden
Responsive
Leiden, The Netherlands
Academisch Ziekenhuis Maastricht
Verified
Maastricht, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

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Investigated drugs

Immunosuppressive Therapy: This therapy involves using medications that help reduce the activity of your immune system. In the context of corneal transplantation, these medications are used to prevent your body from rejecting the new cornea. By lowering the immune response, the therapy helps protect the transplanted tissue, allowing it to heal and function properly. The goal is to find a balance where the immune system is suppressed enough to prevent rejection but not so much that it causes other health issues.

What is already known about the treatment

Medication for Corneal Transplantation (DMEK) – This medication is administered to patients undergoing corneal transplantation, specifically Descemet's Membrane Endothelial Keratoplasty (DMEK), to help prevent the body from rejecting the new corneal tissue. It is currently being studied in clinical trials to determine the best way to use it for both short-term and long-term treatment, aiming to reduce side effects like increased eye pressure and loss of important cells in the eye. The medication works by suppressing the immune system, which helps to prevent it from attacking the transplanted tissue. It falls under the category of immunosuppressive drugs, which are commonly used to help the body accept transplanted organs or tissues.

Investigated diseases

Corneal Transplantation, Descemet's Membrane Endothelial Keratoplasty (DMEK) – This is a surgical procedure used to replace the damaged inner layer of the cornea, known as the endothelium, with a healthy donor tissue. The endothelium is responsible for maintaining the cornea's clarity by pumping out excess fluid. In DMEK, only the thin Descemet's membrane and endothelium are transplanted, which allows for a more precise and less invasive procedure compared to other corneal transplants. Over time, the new endothelial cells help restore the cornea's function and clarity. The healing process involves the integration of the donor tissue with the recipient's cornea, which can lead to improved vision. The progression of recovery is monitored through regular eye examinations to ensure the graft remains clear and functional.