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NCT Number: NCT05741632

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

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Moxifloxacin Ophthalmic Solution

Drug

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

Other names: Molcin(R)

Levofloxacin Ophthalmic

Drug

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

Other names: Cravit(R)

Primary outcomes

  1. Endothelial cell density

    Time frame: 1 month

    Corneal endothelial cell density measured using specular microscopy

Secondary outcomes

  1. Central corneal thickness

    Time frame: 1 month

    Central corneal thickness (in nm) measured using specular microscopy

  2. Central macular thickness

    Time frame: 1 month

    Central macular thickness (in nm) measure using optical coherence tomography

  3. Anterior chamber cell reactions

    Time frame: 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.

  4. Intraocular pressure

    Time frame: 1 month

    Intraocular pressure (in mmHg) measured using automated non contact tonometer

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Ferron Par Pharmaceuticals

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Aug 22, 2023

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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