Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

Universitas Indonesia68 enrolled

Overview

The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile. Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.

This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cataract

Interventions

Moxifloxacin Ophthalmic SolutionDRUG

Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Levofloxacin OphthalmicDRUG

Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Immature senile cataract in one or both eye * Agree to be included and signed informed consent Exclusion Criteria: * Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics * Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders * Ocular surgery prior to study * Sign of infection or inflammation around the eye * Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading * Corneal endothelial cell density \< 1500 cell/ mm2 * Anterior chamber depth \< 2.5 mm * Diabetes mellitus type 2

Locations (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Endothelial cell density

Corneal endothelial cell density measured using specular microscopy

Time frame: 1 month

Secondary Outcomes

Central corneal thickness

Central corneal thickness (in nm) measured using specular microscopy

Time frame: 1 month

Central macular thickness

Central macular thickness (in nm) measure using optical coherence tomography

Time frame: 1 month

Anterior chamber cell reactions

Anterior chamber cell reactions measured in Standardization of Uveitis Nomenclature (SUN) grading. Values consist of 0, trace, 1+, 2+, 3+, and 4+. Higher grading score means more inflammatory reaction which is worse.

Time frame: 1 month

Intraocular pressure

Intraocular pressure (in mmHg) measured using automated non contact tonometer

Time frame: 1 month

Data from ClinicalTrials.gov

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