Study for Optimizing Anti-inflammatory Prophylaxis

PHASE4CompletedINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

December 18, 2019

Study Completion Date

December 18, 2019

Conditions
Postoperative Cystoid Macular EdemaIrvine-Gass Syndrome
Interventions
DRUG

NSAID + prednisolone, preoperative

Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.

DRUG

NSAID + prednisolone, postoperative

Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.

DRUG

NSAID, preoperative

Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.

DRUG

NSAID, postoperative

Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.

DRUG

Drop-less surgery

A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.

Trial Locations (1)

2600

Department of Ophthalmology, Glostrup Municipality

All Listed Sponsors
lead

Line Kessel

OTHER

NCT03383328 - Study for Optimizing Anti-inflammatory Prophylaxis | Biotech Hunter | Biotech Hunter