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Comparison of preservative-free versus preserved dexamethasone and diclofenac eye drops in patients after cataract surgery

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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 treating patients who have undergone cataract surgery. A cataract is a condition where the natural lens of the eye becomes cloudy, making it difficult to see clearly. The study compares two different types of eye drop treatments - one group contains preservatives while the other is preservative-free. The medications being tested are dexamethasone (Monofree Dexamethason and Maxidex) and diclofenac (Dicloabak and Voltaren Ophtha) eye drops.

The purpose of this research is to determine if preservative-free eye drops work better than preserved eye drops after cataract surgery. During the study, participants receive either preservative-free or preserved eye drops for their post-surgery treatment. The treatment continues for 4 weeks after the cataract surgery.

Both types of eye drops contain the same active medicines - dexamethasone, which reduces inflammation, and diclofenac, which helps manage pain and inflammation. The only difference between the two treatment groups is that one contains preservatives while the other does not. The study measures various aspects of eye health, including tear production, eye surface condition, and inflammation levels.

The research process

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

Step 1
Initial eye examination after cataract surgery
Your eyes will be examined after the cataract surgery to establish a baseline for the study.
You will be assigned to one of two treatment groups: either preservative-free eye drops or preserved eye drops.
Step 2
Eye drop treatment begins
You will receive two types of eye drops to use:
Dexamethasone 0.1% eye drops (either Monofree Dexamethason or Maxidex)
Diclofenac 0.1% eye drops (either Dicloabak or Voltaren Ophtha)
Both medications are for ocular use (application directly to the eye)
Step 3
Regular eye examinations
Your eyes will be checked regularly for various factors including:
Tear quality and quantity
Eye surface condition
Eye redness
Cornea (front surface of the eye) health
Macular (central retina) thickness
Step 4
Final assessment
At week 4 after surgery, a final detailed examination will be performed
The main measurement will focus on the level of inflammation inside your eye
Additional measurements will include tear analysis and eye surface condition

Who can join the trial?

7 criteria

You must be 60 years of age or older
You must have been diagnosed with age-related cataract (clouding of the natural lens in your eye that occurs with aging)
Both men and women can participate in the study
You must be able to undergo cataract surgery (a procedure to remove the cloudy lens and replace it with an artificial one)
You must be willing to use eye drops after surgery as prescribed in the study
You must be mentally capable of understanding and providing informed consent for participation
You must not be part of any vulnerable population groups

Who cannot join the trial?

14 criteria

Age below 18 years old
Known allergies to any components of eye drops used in the study
Current eye infections or active inflammation
Previous eye surgery within the last 6 months
Presence of other serious eye conditions besides cataract
Pregnancy or breastfeeding
Participation in another clinical trial within the last 30 days
Inability to follow study instructions or attend follow-up visits
Severe dry eye syndrome (a condition where eyes don't produce enough tears)
Use of contact lenses
Uncontrolled glaucoma (increased pressure inside the eye)
History of complicated cataract surgery
Mental conditions that may affect the ability to provide informed consent
Severe systemic diseases that could interfere with the study

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Dexamethasone is an anti-inflammatory steroid eye drop medication used to reduce inflammation and discomfort after cataract surgery. It helps to decrease swelling, redness, and irritation in the eye following the procedure. Diclofenac is a non-steroidal anti-inflammatory eye drop medication that helps reduce pain and inflammation after cataract surgery. It works by blocking certain substances in the body that cause inflammation and discomfort. Both medications are available in two forms in this trial: preservative-free formulations and formulations containing preservatives. Preservative-free eye drops are generally gentler on the eye's surface and may be better tolerated by some patients, while preserved eye drops contain additional ingredients to keep the medication sterile for longer periods.

What is already known about the treatment

Dexamethasone 0.1% (Monofree Dexamethason)
A preservative-free ophthalmic solution administered as eye drops, used primarily in post-cataract surgery care. This corticosteroid medication works by reducing inflammation and suppressing the immune response at the molecular level in ocular tissues. It belongs to the glucocorticoid class of medications and is particularly valuable in ophthalmology for its anti-inflammatory properties without the potential irritation from preservatives.
Dexamethasone 0.1% (Maxidex)
A preserved ophthalmic solution administered as eye drops, commonly prescribed for post-cataract surgery inflammation management. This corticosteroid medication contains preservatives and works by suppressing inflammatory responses and immune system activity in the eye tissues. It belongs to the glucocorticoid class of medications and is widely used in ophthalmology for its potent anti-inflammatory effects.
Diclofenac 0.1% (Dicloabak)
A preservative-free ophthalmic solution administered as eye drops, used for managing inflammation after cataract surgery. This non-steroidal anti-inflammatory drug (NSAID) works by blocking prostaglandin synthesis, thereby reducing pain and inflammation in ocular tissues. It belongs to the NSAID class of medications and is valued for its anti-inflammatory properties without preservative-related irritation.
Diclofenac 0.1% (Voltaren Ophtha)
A preserved ophthalmic solution administered as eye drops, used in post-cataract surgery care for inflammation control. This non-steroidal anti-inflammatory drug (NSAID) contains preservatives and works by inhibiting prostaglandin synthesis to reduce inflammation and pain in the eye. It belongs to the NSAID class of medications and is commonly prescribed for its effective anti-inflammatory properties.

Investigated diseases

Cataract - A condition where the natural lens of the eye becomes cloudy and opaque, leading to decreased vision quality. The lens gradually loses its transparency as proteins within it break down and clump together, causing light to scatter instead of focusing properly on the retina. This clouding typically develops slowly over time and can affect one or both eyes. Cataracts commonly cause blurred vision, increased glare sensitivity, and changes in color perception. The condition is most often associated with aging, though it can occur at any age.