Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

Phase 2

Not yet recruiting

• Conditions: Endophthalmitis
• Interventions: Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT03244072
• Lead Sponsor: Jason Ahee, M.D.

Brief Summary

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Detailed Description

Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Study Start: 2025-06-01
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

• visually significant cataracts

Exclusion Criteria

• allergy to fluoroquinolones, cobalamin (B12)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Intracameral injection of placebo after cataract surgery
Treatment group	Moxifloxacin	Intracameral injection of moxifloxacin solution after cataract surgery

Primary Outcome Measures

Name	Time	Method
Endophthalmitis after cataract surgery	Subjects will undergo eye examinations at one day, one week, and one month post-operatively	Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.

Trial Locations

Locations (1)

Zion Eye Institute; 🇺🇸 Saint George, Utah, United States