Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Sponsor

Universidade Federal de Pernambuco (Other)

Overall Status

Completed

CT.gov ID

NCT02595359

Collaborator

(none)

1,000

Enrollment

Location

Arm

65.6

Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endophthalmitis	Drug: Moxifloxacin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jun 20, 2018

Actual Study Completion Date :

Jun 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: moxifloxacin intracameral moxifloxacin injection given at conclusion of cataract intervention	Drug: Moxifloxacin Moxifloxacin intracameral Other Names: Vigamox

Arm

Intervention/Treatment

Experimental: moxifloxacin intracameral

moxifloxacin injection given at conclusion of cataract intervention

Drug: Moxifloxacin

Moxifloxacin intracameral

Other Names:

Vigamox

Outcome Measures

Primary Outcome Measures

endothelial cell count [6-month; 1 year; 2 years]

Secondary Outcome Measures

endophthalmitis incidence [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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