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 is this study for? Patients with Age-Related Cataract
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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% (Voltaren Ophtha) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• Patients diagnosed with age-related cataract
• Age 60 years or above
Locations
Other Locations
Belgium
Universitaire Ziekenhuizen Leuven
RECRUITING
Leuven
AZ Delta
RECRUITING
Roeselare
Contact Information
Primary
Heleen Delbeke, MD
heleen.delbeke@uzleuven.be
+32 16 332687
Backup
Ingeborg Stalmans, MD, PhD
ingeborg.stalmans@uzleuven.be
+32 16 332687
Time Frame
Start Date: 2018-10-30
Estimated Completion Date: 2024-12
Participants
Target number of participants: 100
Treatments
Experimental: Preservative-free dexamethasone 0.1%/diclofenac 0.1%
One week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops.
Active_comparator: Preserved dexamethasone 0.1%/diclofenac 0.1%
One week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Laboratoires Thea
Leads: Universitaire Ziekenhuizen KU Leuven