Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin

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

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-04-28

Brief Summary

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Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

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Detailed Description

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Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

Conditions

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Cataract Senile Endophthalmitis Antibiotic Side Effect Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

unlabelled syringe containing interventional drug

Study Groups

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Intracameral levofloxacin

0.5% unpreserved solution

Group Type EXPERIMENTAL

Levofloxacin Ophthalmic

Intervention Type DRUG

0.1 ml of unpreserved 0.5% levofloxacin

Intracameral moxifloxacin

0.5% unpreserved solution

Group Type EXPERIMENTAL

Moxifloxacin Ophthalmic

Intervention Type DRUG

0.1 ml of unpreserved 0.5% moxifloxacin

Interventions

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Levofloxacin Ophthalmic

0.1 ml of unpreserved 0.5% levofloxacin

Intervention Type DRUG

Moxifloxacin Ophthalmic

0.1 ml of unpreserved 0.5% moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eyes undergoing uncomplicated cataract surgery by phacoemulsification

Exclusion Criteria

* Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes