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Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis

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ClinicalTrials.gov Identifier: NCT03363295
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pessoa Cavalcanti Lira, 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.


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


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change of Macular Thickness [ Time Frame: 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 :
  1. Change of Choroidal Thickness [ Time Frame: Change from baseline, 30th day postoperative and 60th day postoperative ]
    Comparison of change in macular thickness using Enhanced Depth Imaging - Optical Coherence Tomography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363295


Contacts
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Contact: Bruna G Ferreira, MD +551935217396 brunagilf@gmail.com

Locations
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Brazil
Hospital das Clínicas da UNICAMP Recruiting
Campinas, São Paulo, Brazil, 13083888
Contact: Bruna G Ferreira, MD    +551935217396    brunagilf@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03363295     History of Changes
Other Study ID Numbers: 002
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco:
endophthalmitis
Additional relevant MeSH terms:
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Endophthalmitis
Cataract
Lens Diseases
Eye Diseases
Eye Infections
Infection
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs