Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

Sponsor

Universidade Federal de Pernambuco (Other)

Overall Status

Completed

CT.gov ID

NCT03363295

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endophthalmitis Macula Edema Cataract	Drug: Moxifloxacin Injection	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Both the patients and the investigator will be masked. The cataract surgeon won't be.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas da UNICAMP	Campinas	São Paulo	Brazil	13083888

Sponsors and Collaborators

Universidade Federal de Pernambuco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de Pernambuco

ClinicalTrials.gov Identifier:

NCT03363295

Other Study ID Numbers:

First Posted:

Dec 6, 2017

Last Update Posted:

May 4, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de Pernambuco

endophthalmitis

Additional relevant MeSH terms:

Endophthalmitis

Cataract

Moxifloxacin

Study Results

No Results Posted as of May 4, 2021