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Trial record 2 of 509 for:    MOXIFLOXACIN

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

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2016)
endothelial cell count [ Time Frame: 6-month; 1 year; 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
endothelial cell count [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT02595359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
endophthalmitis incidence [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Official Title  ICMJE Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Endophthalmitis
Intervention  ICMJE Drug: Moxifloxacin
Moxifloxacin intracameral
Other Name: Vigamox
Study Arms  ICMJE Experimental: moxifloxacin intracameral
moxifloxacin injection given at conclusion of cataract intervention
Intervention: Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2015)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 20, 2018
Actual Primary Completion Date June 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595359
Other Study ID Numbers  ICMJE 0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Lira Prof
PRS Account Universidade Federal de Pernambuco
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP