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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Moxifloxacin Ophthalmic Solution
* Drug: Levofloxacin Ophthalmic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery. | Drug: Moxifloxacin Ophthalmic Solution<br>* Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery<br>* Other names: Molcin(R);|
| Active Comparator: Levofloxacin<br>Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery. | Drug: Levofloxacin Ophthalmic<br>* Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery<br>* Other names: Cravit(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density | Corneal endothelial cell density measured using specular microscopy | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal thickness | Central corneal thickness (in nm) measured using specular microscopy | 1 month | 
| Central macular thickness | Central macular thickness (in nm) measure using optical coherence tomography | 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. | 1 month | 
| Intraocular pressure | Intraocular pressure (in mmHg) measured using automated non contact tonometer | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moxifloxacin, Levofloxacin, Cataract surgery