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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-04-01

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.

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant will be masked receiving treatment, post operative eye drops of both arms is the same. Subject allocation is blinded to investigator and outcomes assessor.

Study Groups

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Moxifloxacin

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

Group Type EXPERIMENTAL

Moxifloxacin Ophthalmic Solution

Intervention Type DRUG

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

Levofloxacin

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

Group Type ACTIVE_COMPARATOR

Levofloxacin Ophthalmic

Intervention Type DRUG

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

Interventions

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Moxifloxacin Ophthalmic Solution

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

Intervention Type DRUG

Levofloxacin Ophthalmic

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

Intervention Type DRUG

Other Intervention Names

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Molcin(R) Cravit(R)

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes