A Phase 4 interventional study of Moxifloxacin Injection in Endophthalmitis, Macula Edema and Cataract, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Universidade Federal de Pernambuco · Phase 4, Interventional, and Prevention
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.
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:
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
Exclusion Criteria:
Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery
Drug: Moxifloxacin Injection
This group won't receive any prophylaxis after phacoemulsification surgery
One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery
Change of Macular Thickness
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
Time frame: Change from baseline, 30th day postoperative and 60th day postoperative
Change of Choroidal Thickness
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
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Pernambuco