Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

NCT03363295 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the macular and choroidal thickness of patients submitted to intracameral moxifloxacin during the phacoemulsification surgery for endophthalmitis prophylaxis. The investigators propose a randomized clinical trial double-blind. The patients will be divided into two groups: one will receive intracameral moxifloxacin injection during phacoemulsification surgery and the other won't. Both Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT) will be performed for each patient pre-operatively and on the 30th and 60th postoperative days. After collecting, the data will be compared to evaluate if there was any difference in the macular thickness and choroidal thickness between the two groups.

Conditions

Endophthalmitis; Macula Edema; Cataract

Keywords

endophthalmitis

Outcome Measures

Primary Outcomes (1)

• Change of Macular Thickness

  Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography

  Change from baseline, 30th day postoperative and 60th day postoperative

Secondary Outcomes (1)

• Change of Choroidal Thickness

  Change from baseline, 30th day postoperative and 60th day postoperative

Study Arms (2)

Intracameral moxifloxacin

EXPERIMENTAL

Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery

Drug: Moxifloxacin Injection

No - Intracameral moxifloxacin

NO INTERVENTION

This group won't receive any prophylaxis after phacoemulsification surgery

Interventions

Moxifloxacin Injection DRUG

One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery

Intracameral moxifloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients that will be submitted to phacoemulsification surgery in the Hospital de Clinicas of State University of Campinas (BRAZIL)
• Patients over 18 years old
• Patients who are able to perform SD-OCT
• Patients who sign the consent form

You may not qualify if:

• Diabetic patients
• Patients with any macular changes prior to the surgery (epiretinal membranes, age macular disease, macular edema...)
• Patients who had any complication during phacoemulsification surgery

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital das Clínicas da UNICAMP

Campinas, São Paulo, 13083888, Brazil

Location

Related Publications (1)

• Ferreira BG, Cardoso da Silva I, Melega MV, Nascimento MA, Cavalcanti Lira RP, Leite Arieta CE, Alves M. Macular and choroidal thickness after intracameral moxifloxacin for prevention of postcataract endophthalmitis. J Cataract Refract Surg. 2021 Jan 1;47(1):40-45. doi: 10.1097/j.jcrs.0000000000000365.

  PMID: 32818353 DERIVED

MeSH Terms

Conditions

Endophthalmitis; Cataract

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mathias V Mélega, MD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the patients and the investigator will be masked. The cataract surgeon won't be.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2017
• First Posted: December 6, 2017
• Study Start: July 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)