Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03363295|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : October 4, 2019
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|
Evaluation and Comparison of Macular and Choroidal Thickness after Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
The objective of this study is to evaluate if the using of intracameral moxifloxacin cause changes in macular and choroidal thickness.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363295
|Contact: Bruna G Ferreira, MDemail@example.com|
|Hospital das Clínicas da UNICAMP||Recruiting|
|Campinas, São Paulo, Brazil, 13083888|
|Contact: Bruna G Ferreira, MD +551935217396 firstname.lastname@example.org|