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Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

NCT03363295 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-11-03

No results posted yet for this study

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

Interventions

DRUG

Moxifloxacin Injection

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

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Mathias V Mélega, MD · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363295 on ClinicalTrials.gov