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Completed

NCT Number: NCT02595359

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

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

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UFPE Ophthalmology

Recife, Pernambuco, 50740600, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

Moxifloxacin intracameral

Other names: Vigamox

Primary outcomes

  1. endothelial cell count

    Time frame: 6-month; 1 year; 2 years

Secondary outcomes

  1. endophthalmitis incidence

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2015
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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