Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595359
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pessoa Cavalcanti Lira, 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.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Study Start Date : January 2013
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. endothelial cell count [ Time Frame: 6-month; 1 year; 2 years ]

Secondary Outcome Measures :
  1. endophthalmitis incidence [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595359


Locations
Layout table for location information
Brazil
UFPE Ophthalmology
Recife, PE, Brazil, 50740600
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Layout table for investigator information
Principal Investigator: Rodrigo Lira Prof

Layout table for additonal information
Responsible Party: Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02595359     History of Changes
Other Study ID Numbers: 0001
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided
Keywords provided by Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco:
endophthalmitis
antibiotic therapy
cataract surgery
prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Endophthalmitis
Eye Infections
Infection
Eye Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs