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Completed

NCT Number: NCT04403334

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

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

Completed

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Key information

Conditions

Cataract Senile Antibiotic Side Effect Endophthalmitis Eye Diseases Eye Infections Infections Safety Issues

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peregrine Eye and Laser Instittute

Makati City, MM, 1209, Philippines

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin Ophthalmic

Drug

0.1 ml of unpreserved 0.5% levofloxacin

Moxifloxacin Ophthalmic

Drug

0.1 ml of unpreserved 0.5% moxifloxacin

Primary outcomes

  1. Endothelial Cell Count

    Time frame: 3 months

    Change in endothelial cell count as measured by specular microscopy

  2. Central Retina Thickness

    Time frame: 3 months

    Change in central retinal thickness as measured by spectral domain optical coherence tomography

Secondary outcomes

  1. Adverse Events

    Time frame: 3 months

    Onset of Adverse events following intervention

Sponsors and collaborators

Lead sponsor

Peregrine Eye and Laser Institute

Other

Registry information

Official study title

Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 27, 2020
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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