Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

• ClinicalTrials.gov Identifier: NCT02595359
• Recruitment Status: Completed
• First Posted: November 3, 2015
• Last Update Posted: April 24, 2019
• Sponsor: Universidade Federal de Pernambuco
• Information provided by (Responsible Party): Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco

Tracking Information

• First Submitted Date: November 2, 2015
• First Posted Date: November 3, 2015
• Last Update Posted Date: April 24, 2019
• Study Start Date: January 2013
• Actual Primary Completion Date: June 20, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2016): endothelial cell count [ Time Frame: 6-month; 1 year; 2 years ]
• Original Primary Outcome Measures (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 (submitted: November 2, 2015): endophthalmitis incidence [ Time Frame: 1 month ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Endophthalmitis

Intervention

Drug: Moxifloxacin

Moxifloxacin intracameral

Other Name: Vigamox

Study Arms

Experimental: moxifloxacin intracameral

moxifloxacin injection given at conclusion of cataract intervention

Intervention: Drug: Moxifloxacin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2015): 1000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 20, 2018
• Actual Primary Completion Date: June 20, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT02595359
• Other Study ID Numbers: 0001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: undecided

• Responsible Party: Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
• Study Sponsor: Universidade Federal de Pernambuco
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rodrigo Lira; Prof

• PRS Account: Universidade Federal de Pernambuco
• Verification Date: April 2019