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

Phase 1

Completed

• Conditions: Cataract
• Interventions: Drug: Moxifloxacin Ophthalmic Solution; Drug: Levofloxacin Ophthalmic

• Registration Number: NCT05741632
• Lead Sponsor: Indonesia University

Brief Summary

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

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 Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin Ophthalmic Solution	Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.
Levofloxacin	Levofloxacin Ophthalmic	Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.

Primary Outcome Measures

Name	Time	Method
Endothelial cell density	1 month	Corneal endothelial cell density measured using specular microscopy

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	1 month	Intraocular pressure (in mmHg) measured using automated non contact tonometer
Central corneal thickness	1 month	Central corneal thickness (in nm) measured using specular microscopy
Central macular thickness	1 month	Central macular thickness (in nm) measure using optical coherence tomography
Anterior chamber cell reactions	1 month	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.

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia