Evaluation and Comparison of Macular and Choroidal Thickness After Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of Macular Thickness
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Both the patients and the investigator will be masked. The cataract surgeon won't be.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intracameral moxifloxacin
Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery
Intervention: Moxifloxacin Injection (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Change of Choroidal Thickness(Change from baseline, 30th day postoperative and 60th day postoperative)
Investigators
Rodrigo Pessoa Cavalcanti Lira
Professor
Universidade Federal de Pernambuco