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

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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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 trial?

13 criteria

  • 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
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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.

What is already known about the treatment

  • Topical NSAIDs

    A class of eye drops containing non-steroidal anti-inflammatory drugs used to reduce inflammation after glaucoma surgery. These medications work by blocking specific enzymes involved in the inflammatory process, helping to control post-surgical healing and maintain proper intraocular pressure. They are commonly prescribed as an alternative or complement to steroid medications in ophthalmology, particularly after trabeculectomy procedures.

  • Topical Steroids

    Eye drops containing corticosteroids that are used to suppress inflammation and immune response following glaucoma surgery. These medications work by inhibiting multiple inflammatory pathways, reducing swelling and preventing excessive scarring after trabeculectomy. They are a standard post-operative treatment in ophthalmology, though their long-term use requires careful monitoring due to potential side effects like increased intraocular pressure.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523957-32-00Estimated enrolment72 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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