Clinical trial NCT03363295: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endophthalmitis
Macula Edema
Cataract
Keywords: endophthalmitis
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Change of Macular Thickness
timeFrame: Change from baseline, 30th day postoperative and 60th day postoperative
Secondary outcomes:
measure: Change of Choroidal Thickness
timeFrame: Change from baseline, 30th day postoperative and 60th day postoperative
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital das Clínicas da UNICAMP
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Mathias V Mélega, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.