RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients diagnosed with age-related cataract - Age 60 years or above Who Should NOT Join This Trial: - Unwilling to sign willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Preservative Free drop treatment

Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

DRUG

Preserved drop treatment

Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

Locations (2)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium