drugset / Trial / NCT03634852

A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery

NCT03634852

Phase 4 Completed 1000 enrolled Suzan A Rattan Al-Kindy College of Medicine · collab
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome. The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC) antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most common pattern in the United state(US). The current study aimed to evaluate the effectivity and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five hundred phacoemulsification surgeries and compare its results with the same number of patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given four times a day for 1month postoperatively.

Timeline

Start
2016-10-01
Primary completion
2018-02-01
Completion
2018-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.1 %
Comparator Moxifloxacin Small molecule 0.1 % Topical
Comparator Moxifloxacin Small molecule 0.5 % Topical
Comparator Triamcinolone Acetonide Other / unclassified 4 mg Other

Indications