Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 20, 2018

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.

Interventions

  • Drug: Moxifloxacin
    • Moxifloxacin intracameral

Arms, Groups and Cohorts

  • Experimental: moxifloxacin intracameral
    • moxifloxacin injection given at conclusion of cataract intervention

Clinical Trial Outcome Measures

Primary Measures

  • endothelial cell count
    • Time Frame: 6-month; 1 year; 2 years

Secondary Measures

  • endophthalmitis incidence
    • Time Frame: 1 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Federal de Pernambuco
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rodrigo Pessoa Cavalcanti Lira, Professor – Universidade Federal de Pernambuco
  • Overall Official(s)
    • Rodrigo Lira, Principal Investigator, Prof

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