Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Phase 2

Completed

• Conditions: Endophthalmitis
• Interventions: Drug: Moxifloxacin

• Registration Number: NCT02595359
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Detailed Description

Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.

As endophthalmitis is an infection, it should be preventable by antibiotic treatment.

Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Diagnosis of visually significant cataract

Exclusion Criteria

• Has known allergies to moxifloxacin
• Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
• Has a known history of a condition which causes an immuno-compromised host state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
moxifloxacin intracameral	Moxifloxacin	moxifloxacin injection given at conclusion of cataract intervention

Primary Outcome Measures

Name	Time	Method
endothelial cell count	6-month; 1 year; 2 years

Secondary Outcome Measures

Name	Time	Method
endophthalmitis incidence	1 month

Trial Locations

Locations (1)

UFPE Ophthalmology; 🇧🇷 Recife, PE, Brazil