Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis
Primary Purpose
Endophthalmitis, Macula Edema, Cataract
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Moxifloxacin Injection
Sponsored by
About this trial
This is an interventional prevention trial for Endophthalmitis focused on measuring endophthalmitis
Eligibility 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
Sites / Locations
- Hospital das Clínicas da UNICAMP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intracameral moxifloxacin
No - Intracameral moxifloxacin
Arm Description
Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery
This group won't receive any prophylaxis after phacoemulsification surgery
Outcomes
Primary Outcome Measures
Change of Macular Thickness
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
Secondary Outcome Measures
Change of Choroidal Thickness
Comparison of change in macular thickness using Enhanced Depth Imaging - Optical Coherence Tomography
Full Information
NCT ID
NCT03363295
First Posted
November 25, 2017
Last Updated
November 2, 2022
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03363295
Brief Title
Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis
Official Title
Evaluation and Comparison of Macular and Choroidal Thickness After Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis, Macula Edema, Cataract
Keywords
endophthalmitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Both the patients and the investigator will be masked. The cataract surgeon won't be.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intracameral moxifloxacin
Arm Type
Experimental
Arm Description
Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery
Arm Title
No - Intracameral moxifloxacin
Arm Type
No Intervention
Arm Description
This group won't receive any prophylaxis after phacoemulsification surgery
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Injection
Intervention Description
One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery
Primary Outcome Measure Information:
Title
Change of Macular Thickness
Description
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
Time Frame
Change from baseline, 30th day postoperative and 60th day postoperative
Secondary Outcome Measure Information:
Title
Change of Choroidal Thickness
Description
Comparison of change in macular thickness using Enhanced Depth Imaging - Optical Coherence Tomography
Time Frame
Change from baseline, 30th day postoperative and 60th day postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias V Mélega, MD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da UNICAMP
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083888
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32818353
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis
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