PCME Prevention in Patients With NPDR

PHASE4CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 1, 2021

Primary Completion Date

October 1, 2021

Study Completion Date

January 1, 2022

Conditions
Cystoid Macular Edema Following Cataract Surgery
Interventions
DRUG

Bromfenac Ophthalmic 0.09% Ophthalmic Solution

topical bromfenac (0.9 mg/mL) 2x daily 7 days before the surgery

DRUG

Dexamethasone Ophthalmic

topical dexamethasone (1 mg/mL) 2x daily 7 days before the surgery

DRUG

Placebo

topical placebo (artificial tears substitute) 2x daily before the surgery

PROCEDURE

Phacoemulsification surgery (PHACO)

About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R\&D System).

Trial Locations (1)

10000

KBCZagreb, Zagreb

All Listed Sponsors
collaborator

University of Zagreb

OTHER

lead

Klinički Bolnički Centar Zagreb

OTHER