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Comparing diclofenac sodium eye drops versus dexamethasone phosphate eye drops for recovery after vitrectomy in patients with macular disorders

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 comparing two different types of eye drops used after vitrectomy, a surgical procedure performed to treat various eye conditions including macular hole, vitreomacular traction syndrome, and macular pucker. These conditions affect the central part of the retina, which is responsible for detailed vision. The study will compare the effectiveness of anti-inflammatory eye drops (Dicloabak) against steroid eye drops (Monofree Dexamethasone) in post-surgical care.

The main purpose of this research is to determine if using anti-inflammatory eye drops instead of steroid drops leads to fewer cases of increased eye pressure after surgery. During the study, participants will receive either anti-inflammatory or steroid eye drops following their eye surgery. Some patients may also receive a single injection of triamcinolone acetonide during the surgical procedure.

The treatment period will last for six weeks, during which patients will use the prescribed eye drops several times per day. Throughout the study, doctors will monitor various aspects of eye healing, including eye pressure, inflammation, and the condition of the retina. Regular check-ups will be performed to ensure proper healing and to monitor any changes in eye health.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial eye surgery
You will undergo a vitrectomy (eye surgery) for treating conditions such as macular hole, macular pucker, or vitreomacular traction syndrome.
The surgery may be performed with or without phaco-emulsification (cataract removal).
Step 2
Post-surgery medication group assignment
After surgery, you will be assigned to receive either:
Group 1: NSAID eye drops (Dicloabak 1 mg/ml eye drops solution) or
Group 2: Steroid eye drops (Monofree Dexamethasone 1 mg/ml eye drops solution)
Step 3
Follow-up visit - Day 3
Your eye will be examined to measure inflammation levels using a special light measurement device.
This visit may occur within 2 days before or after the scheduled date.
Step 4
Follow-up visit - Week 2
Your eye pressure will be measured and compared to initial values.
Eye inflammation levels will be checked again.
Step 5
Follow-up visit - Week 8
Another eye pressure measurement will be taken.
Eye inflammation levels will be checked once more.
Step 6
Follow-up visit - Month 2
An OCT scan (detailed eye imaging) will be performed to examine your retina and measure any swelling.
Step 7
Final follow-up visit - Month 6
A final OCT scan will be performed to assess your eye's condition.
This completes your participation in the study.

Who can join the trial?

7 criteria

You must be at least 18 years old
You must be scheduled for vitrectomy (a type of eye surgery where the gel-like substance inside the eye is removed) for one of these conditions:
- Macular pucker (wrinkled tissue on the central part of the retina)
- Vitreomacular traction (when the gel inside the eye pulls on the retina)
- Macular hole (a small break in the center of the retina)
- If you are female, you must be either:
  - Post-menopausal (no menstrual periods for 12 consecutive months or more without other medical cause)
  - Or surgically sterile (having had surgery to remove the uterus or both ovaries)
  - You must be willing and able to provide written informed consent before any study procedures begin

Who cannot join the trial?

15 criteria

Age under 18 years or over 65 years
Previous vitrectomy surgery (surgery to remove the gel-like substance from the eye) in the same eye
Known allergy to NSAIDs (non-steroidal anti-inflammatory drugs) or steroid eye drops
Current eye infection or inflammation
Uncontrolled glaucoma (increased pressure inside the eye)
Pregnancy or breastfeeding
Participation in another clinical trial within the last 30 days
Severe systemic diseases that could affect eye healing
History of poor response to eye medications
Unable to follow post-operative care instructions
Known bleeding disorders or current use of blood thinners
Active eye disease other than the conditions being studied (macular hole, vitreomacular traction syndrome, or macular pucker)
History of chronic eye inflammation
Inability to attend follow-up visits
Mental conditions that prevent understanding of consent process

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

NSAID eyedrops
are non-steroidal anti-inflammatory medications in the form of eye drops. These drops help reduce inflammation and pain in the eye after surgery. They work by blocking certain chemicals in the body that cause inflammation, without the side effects commonly associated with steroids.
Steroid eyedrops
contain corticosteroids that are used to treat inflammation in the eye after surgery. These drops are powerful anti-inflammatory medications that work by suppressing the immune system response. While effective at reducing inflammation, they may cause increased pressure inside the eye in some patients.

What is already known about the treatment

NSAID Eye Drops
A topical ophthalmic medication administered as drops directly into the eye, belonging to the non-steroidal anti-inflammatory drug class. These drops work by blocking specific enzymes (cyclooxygenase) that produce prostaglandins, thereby reducing inflammation and pain in the eye tissue. They are commonly used after eye surgeries, particularly vitrectomy, to manage post-operative inflammation and discomfort, with the advantage of not causing intraocular pressure elevation typically associated with steroid medications.
Steroid Eye Drops
A topical corticosteroid medication delivered as drops into the eye, designed to suppress multiple inflammatory pathways in ocular tissues. These drops are widely used post-operatively in eye surgeries, including vitrectomy, to control inflammation and promote healing, though they may cause elevated intraocular pressure as a side effect. They work by inhibiting various inflammatory mediators and reducing the immune response in the eye tissue, making them effective but requiring careful monitoring during treatment.

Investigated diseases

Macular hole
A condition where a small break develops in the macula, the central part of the retina responsible for detailed vision. The hole typically begins gradually as the vitreous gel inside the eye pulls on the macula, creating a small defect that can enlarge over time. This condition affects central vision, making it difficult to see fine details, read, or recognize faces.
Vitreomacular traction syndrome
A disorder where the vitreous gel in the eye adheres abnormally to the surface of the macula while pulling away from it. The pulling force creates distortion of the macula's normal anatomy. This condition can cause visual disturbances, including blurred and distorted central vision.
Macular pucker
A condition where a thin layer of scar tissue forms on the surface of the macula, causing it to wrinkle or pucker. This occurs when cells grow and contract on the surface of the retina, leading to distorted central vision. The scar tissue pulls on the macula, resulting in wavy or blurry central vision.