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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Laboratoires Thea
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Diclofenac; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Patients diagnosed with age-related cataract

• Age 60 years or above

Exclusion Criteria:

• 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