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Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Primary Purpose

Endophthalmitis

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Moxifloxacin

About this trial

This is an interventional prevention trial for Endophthalmitis focused on measuring endophthalmitis, antibiotic therapy, cataract surgery, prevention

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UFPE Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

moxifloxacin intracameral

Arm Description

moxifloxacin injection given at conclusion of cataract intervention

Outcomes

Primary Outcome Measures

endothelial cell count

Secondary Outcome Measures

endophthalmitis incidence

Full Information

NCT ID

NCT02595359

First Posted

November 2, 2015

Last Updated

April 22, 2019

Sponsor

Universidade Federal de Pernambuco

1. Study Identification

Unique Protocol Identification Number

NCT02595359

Brief Title

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Official Title

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 20, 2018 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endophthalmitis

Keywords

endophthalmitis, antibiotic therapy, cataract surgery, prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

moxifloxacin intracameral

Arm Type

Experimental

Arm Description

moxifloxacin injection given at conclusion of cataract intervention

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Other Intervention Name(s)

Vigamox

Intervention Description

Moxifloxacin intracameral

Primary Outcome Measure Information:

Title

endothelial cell count

Time Frame

6-month; 1 year; 2 years

Secondary Outcome Measure Information:

Title

endophthalmitis incidence

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo Lira

Organizational Affiliation

Prof

Official's Role

Principal Investigator

Facility Information:

Facility Name

UFPE Ophthalmology

City

Recife

State/Province

ZIP/Postal Code

50740600

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

undecided

Learn more about this trial

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

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