Status:
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
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Laboratoires Thea
Conditions:
Age-related Cataract
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
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% (Volt...
Detailed Description
Cataract surgery is a standardized procedure yielding excellent visual outcomes in most patients. According to Daien et al., the incidence of cataract surgery in 2012 in France was 11/1000 person-year...
Eligibility Criteria
Inclusion
- Patients diagnosed with age-related cataract
- Age 60 years or above
Exclusion
- Unwilling to sign informed consent
- Pseudoexfoliation syndrome
- Functionally monocular patient
- Any use of eye drops during at least 3 months before surgery with the exception of artificial tears
- Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report
- Previous ocular surgery, laser treatment or uveitis, with the exception of retinal laser treatment (more than 6 months ago) and iridotomy (more than 6 months ago)
- Active conjunctivitis
- Wearing of contact lens
- Presence of any macular diseases possibly impacting visual acuity
- Presence of any ocular diseases leading to difficulty to have a correct eye examination
- Known or suspected allergy to any of the ingredients on the study medications
- Presence of uncontrolled systemic disease
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04050644
Start Date
October 30 2018
End Date
December 1 2024
Last Update
July 1 2024
Active Locations (2)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
2
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800