Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Endophthalmitis; Macula Edema
• Intervention / Treatment: Drug: Moxifloxacin Injection

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083888
      • Hospital das Clínicas da Unicamp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracameral moxifloxacin; Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery	Drug: Moxifloxacin Injection; One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery
No Intervention: No - Intracameral moxifloxacin; This group won't receive any prophylaxis after phacoemulsification surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Mathias V Mélega, MD, University of Campinas, Brazil

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: endophthalmitis
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Lens Diseases; Eye Infections; Cataract; Endophthalmitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes