Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

Phase 4

Completed

• Conditions: Macula Edema; Cataract; Endophthalmitis
• Interventions: Drug: Moxifloxacin Injection

• Registration Number: NCT03363295
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Title:

Evaluation and Comparison of Macular and Choroidal Thickness after Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Purpose:

The objective of this study is to evaluate if the using of intracameral moxifloxacin cause changes in macular and choroidal thickness.

Methods:

A randomized clinical trial will be conducted in the Hospital of Clinics at State University of Campinas (UNICAMP). The patients that will be submitted to phacoemulsification surgery will be divided into two groups. The first group will receive 0,03ml intracameral moxifloxacin after phacoemulsification surgery, while the second group won't receive any antibiotics intracamerally. Both groups will apply eyedrops as usual in the postoperative.

The investigators will evaluate those patients blindly. Each patient will be examined using Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT), in the pre-operative, at the 30th postoperative and at the 60th postoperative. The data will be collected regarding macular central thickness and choroidal thickness.

The exclusion criteria will be:

* Patients who had any macular changes prior to the surgery (including epiretinal membrane, macular edema, drusen or any other)

* diabetic patients

* patients who had any complications during the cataract surgery

* patients who refuse to participate in the trial, or refuse to sign the consent form

After collecting data, the two groups will be compared regarding changes in macular thickness and choroidal thickness from the pre-operative, the 30th and the 60th postoperative.

The investigators expect that there will be no statistical difference between groups

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-06
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracameral moxifloxacin	Moxifloxacin Injection	Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery

Primary Outcome Measures

Name	Time	Method
Change of Macular Thickness	Change from baseline, 30th day postoperative and 60th day postoperative	Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography

Secondary Outcome Measures

Name	Time	Method
Change of Choroidal Thickness	Change from baseline, 30th day postoperative and 60th day postoperative	Comparison of change in macular thickness using Enhanced Depth Imaging - Optical Coherence Tomography

Trial Locations

Locations (1)

Hospital das Clínicas da UNICAMP; 🇧🇷 Campinas, São Paulo, Brazil