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

University of Indonesia (UI)

Status and phase: Completed; Phase 1

Conditions: Cataract

Treatments: Drug: Moxifloxacin Ophthalmic Solution; Drug: Levofloxacin Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT05741632

KET-1303/UN2.F1/ETIK/PPM.00.02 (Other Identifier)

22-10-1262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Moxifloxacin

Experimental group

Description:

Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.

Treatment:

Drug: Moxifloxacin Ophthalmic Solution

Levofloxacin

Active Comparator group

Description:

Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.

Treatment:

Drug: Levofloxacin Ophthalmic