Actively Recruiting
Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
100
Participants Needed
2
Research Sites
317 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
L
Laboratoires Thea
Collaborating Sponsor
AI-Summary
What this Trial Is About
To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.
CONDITIONS
Official Title
Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with age-related cataract
- Age 60 years or above
You will not qualify if you...
- Unwilling to sign informed consent
- Pseudoexfoliation syndrome
- Functionally monocular patient
- Any use of eye drops during at least 3 months before surgery except artificial tears
- Pre-existing dry eye disease as defined by TFOS DEXS II report
- Previous ocular surgery, laser treatment, or uveitis except retinal laser treatment or iridotomy more than 6 months ago
- Active conjunctivitis
- Wearing contact lenses
- Presence of macular diseases possibly affecting vision
- Presence of ocular diseases making eye exam difficult
- Known or suspected allergy to study medications
- Presence of uncontrolled systemic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
2
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
Research Team
H
Heleen Delbeke, MD
CONTACT
I
Ingeborg Stalmans, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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