Comparison of Dexamethasone and Diclofenac Eye Drops After Glaucoma Surgery in Patients with Medically Uncontrolled Glaucoma

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What is this study about?

This study focuses on patients with medically uncontrolled glaucoma who require a surgical procedure called trabeculectomy (an operation to lower pressure inside the eye). The study compares different anti-inflammatory treatments used after the surgery to determine which method provides better long-term control of eye pressure.

The study examines two types of eye drops: Monopex (containing dexamethasone phosphate, a steroid medication) and Voltaren ophtha (containing diclofenac sodium, a non-steroidal anti-inflammatory drug). Some patients will receive steroid eye drops, some will receive non-steroid anti-inflammatory drops, and others will receive a combination of both medications. The treatment period lasts for 10 days after the surgery.

The main purpose is to determine which type of anti-inflammatory eye drops works best for controlling eye pressure after trabeculectomy surgery. The study will monitor patients’ eye pressure and other eye health measures for up to 24 months after the surgery. This includes checking vision quality, examining the surgical site, and measuring the thickness of certain parts of the eye using special imaging techniques.

1 Initial eye surgery

You will undergo a trabeculectomy, which is a surgical procedure to treat glaucoma.

The surgery will be performed on one eye only, even if both eyes require treatment.

2 Post-surgery treatment

After surgery, you will receive one of the following eye drop treatments:

– Dexamethasone phosphate (steroid eye drops)

– Diclofenac sodium (anti-inflammatory eye drops)

– A combination of both types of eye drops

3 12-month follow-up

Your eye pressure will be measured using a special instrument

Additional tests will include:

– Vision check

– Visual field examination

– Eye nerve scanning using optical imaging

– Lens examination

– Examination of the surgical site

4 24-month follow-up

The same tests performed at 12 months will be repeated:

– Eye pressure measurement

– Vision check

– Visual field examination

– Eye nerve scanning

– Lens examination

– Examination of the surgical site

Who Can Join the Study?

Must be diagnosed with one of the following eye conditions:
- Primary open-angle glaucoma (POAG) – a condition where pressure inside the eye is elevated
- Pseudoexfoliation syndrome (PEX) – a condition where protein fibers build up in the eye
- Pigment dispersion syndrome (PDS) – a condition where pigment from the iris spreads within the eye
- Ocular hypertension – high pressure inside the eye
Must be over 50 years of age
Female participants must be postmenopausal (no menstrual periods for at least 12 months)
Must be scheduled for trabeculectomy surgery (a procedure to lower eye pressure)
Only one eye can be included in the study (if both eyes are eligible, the study eye will be chosen randomly)
Must be able to understand and sign informed consent
Must be willing and able to follow all study procedures

Who Cannot Join the Study?

Previous glaucoma surgery (surgery to reduce pressure in the eye) in the study eye
Active eye infection or inflammation
Known allergy or sensitivity to study medications (anti-inflammatory eye drops)
Pregnant or breastfeeding women
Severe health conditions that could interfere with follow-up visits
Current participation in other clinical trials
Inability to use eye drops properly
History of poor compliance with medical treatments
Uncontrolled systemic diseases (conditions affecting the whole body) that could affect eye healing
Use of blood-thinning medications that could increase surgical risks
Unable to provide informed consent
Unable to attend required follow-up visits for 12 months
History of serious adverse reactions to similar medications

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
These are anti-inflammatory eye drops containing steroids that help reduce inflammation after glaucoma surgery. They are commonly used to prevent scarring and promote healing after trabeculectomy (glaucoma surgery).

Topical NSAIDs
These are non-steroidal anti-inflammatory eye drops that help reduce inflammation and pain after glaucoma surgery. They work differently from steroids by blocking specific inflammation-causing substances in the eye.

Combination therapy
This treatment combines both topical steroids and NSAIDs eye drops, potentially offering the benefits of both types of anti-inflammatory medications in managing post-surgical inflammation after glaucoma surgery.

Investigated diseases:

Glaucoma

Glaucoma – A progressive eye condition characterized by increased pressure within the eye (intraocular pressure) that damages the optic nerve. The condition typically develops gradually, causing a buildup of fluid in the front part of the eye, which creates pressure on the optic nerve. This pressure can lead to the gradual loss of peripheral vision and, if untreated, may affect central vision. Glaucoma often occurs without early warning signs, making regular eye examinations crucial for detection. The condition can affect one or both eyes and is more common in older adults.

Trial ID:

2025-523957-32-00

NCT ID:

NCT04054830

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of Dexamethasone and Diclofenac Eye Drops After Glaucoma Surgery in Patients with Medically Uncontrolled Glaucoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?