Study on Diclofenac Sodium and Dexamethasone Phosphate for Patients with Uncontrolled Glaucoma After Surgery

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What is this study about?

This clinical trial is focused on studying treatments for glaucoma, a condition where increased pressure in the eye can lead to vision loss. The study is specifically looking at patients with medically uncontrolled glaucoma who need a type of eye surgery called trabeculectomy. The trial will compare different anti-inflammatory treatments used after this surgery to see which one helps control eye pressure better in the long term. The treatments being tested include eye drops containing diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone phosphate, a steroid. Some patients may receive a combination of both treatments, while others may receive a placebo.

The purpose of the study is to find out which treatment is most effective in managing eye pressure after surgery. Participants will use the eye drops for a period of up to 10 days following their surgery. The study will monitor the eye pressure of participants over a period of 12 months to assess the effectiveness of the treatments. This will help researchers understand the best way to manage eye pressure after glaucoma surgery and explore the underlying mechanisms of the disease.

Throughout the study, participants will have their eye pressure measured using a method called applanation tonometry, which is a standard way to check the pressure inside the eye. The study will also look at other factors such as changes in vision, the health of the optic nerve, and the success of the surgery over a period of 24 months. This research aims to improve the care and outcomes for patients undergoing surgery for glaucoma.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate and understand the procedures involved.

You will be scheduled for a trabeculectomy surgery at the Department of Ophthalmology. This is a type of eye surgery to help manage glaucoma.

2 post-surgery medication

After the surgery, you will be given eye drops to use. These include Voltaren® ophtha sine and Monopex. These are anti-inflammatory medications to help with healing.

The eye drops are to be used as directed by your healthcare provider. The frequency and dosage will be explained to you during your follow-up visits.

3 follow-up visits

You will have regular follow-up visits to monitor your intraocular pressure (the pressure inside your eye) and overall eye health.

These visits will occur at various intervals, including 12 months and 24 months after your surgery. During these visits, tests will be conducted to assess your eye’s condition.

4 assessments and tests

At each follow-up, your visual acuity (clarity of vision) will be tested. This helps determine how well you can see.

Other tests include checking the visual field (the area you can see without moving your eyes) and examining the optic nerve for any changes.

5 final evaluation

At the end of the study period, a final evaluation will be conducted to assess the long-term effects of the treatment on your eye health.

The primary focus will be on the control of intraocular pressure and any changes in your vision or eye structure.

Who Can Join the Study?

Patients must have one of the following conditions: primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS), or ocular hypertension.
Patients must be older than 50 years.
Women must be postmenopausal. This means they have not had a menstrual period in the last 12 months.
Patients must be scheduled to have a specific type of eye surgery called trabeculectomy.
Only one eye per participant can be included in the study. If both eyes are eligible, it will be randomly decided which eye to include.
Patients must give informed consent to participate, meaning they understand the study and agree to take part.
Patients must be able to follow the study procedures.

Who Cannot Join the Study?

Patients with medically uncontrolled glaucoma that requires filtration surgery cannot participate. This means if your glaucoma is not being managed well with medication and you need a specific type of surgery to help control it, you cannot join the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.08.2019

Trial locations

Investigated drugs:

Topical Steroids are medications applied directly to the eye to reduce inflammation. In this trial, they are used after glaucoma surgery to help control eye pressure and prevent inflammation, which can improve healing and the overall success of the surgery.

Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are another type of medication applied to the eye to reduce inflammation. Unlike steroids, they work by blocking certain substances in the body that cause inflammation. In this study, they are being tested to see if they can effectively control eye pressure and inflammation after glaucoma surgery.

The trial also explores the use of a combination of Topical Steroids and NSAIDs. This approach uses both types of medications together to see if they provide better control of eye pressure and inflammation after surgery compared to using each one alone. The goal is to find the most effective treatment for patients recovering from glaucoma surgery.

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, often due to high intraocular pressure. It progresses slowly and can lead to vision loss if not managed. The disease typically starts with peripheral vision loss, which may go unnoticed until it becomes more severe. Over time, the damage can extend to central vision, affecting the ability to see clearly. The progression of glaucoma can vary, with some individuals experiencing rapid changes while others have a more gradual decline. Regular monitoring of intraocular pressure and optic nerve health is crucial to understanding its progression.

Trial ID:

2024-511820-15-03

NCT ID:

NCT04054830

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Diclofenac Sodium and Dexamethasone Phosphate for Patients with Uncontrolled Glaucoma After Surgery

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