NCT03383328

Study for Optimizing Anti-inflammatory Prophylaxis

Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Line Kessel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.

Conditions

• Postoperative Cystoid Macular Edema
• Irvine-Gass Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2017-12-26
• Last updated: 2019-12-20

Locations

1 site across 1 country: Denmark