Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This randomized study aims to compare the safety and efficacy of intracameral levofloxacin versus intracameral moxifloxacin administered at the end of phacoemulsification cataract surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Senile cataract scheduled for elective cataract surgery

Undergoing standard phacoemulsification with foldable posterior chamber IOL implantation

Healthy corneal endothelium with normal cell count on specular microscopy

Written informed consent

Disqualifiers

- Active ocular infection or inflammation

Complicated or traumatic cataract requiring non-standard surgical approach

Known hypersensitivity to levofloxacin or moxifloxacin

Unable or unwilling to comply with the postoperative follow-up schedule

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levofloxacin

    Drug

    0.1 mL of preservative-free levofloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification.

  • Moxifloxacin

    Drug

    0.1 mL of preservative-free moxifloxacin 0.5% injected into the anterior chamber at the end of phacoemulsification.

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Intracameral LevofloxacinExperimental treatment 1 intervention
Group B: Intracameral MoxifloxacinActive comparator 1 intervention
Group C: No Intracameral AntibioticNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of postoperative endophthalmitis

Proportion of eyes that develop culture-proven or clinically diagnosed postoperative endophthalmitis.

Time frame
1 month

Secondary outcomes

1

Mean best-corrected visual acuity

Mean best-corrected visual acuity (BCVA) in logMAR

Time frame
1 month
2

Mean endothelial cell density

Mean corneal endothelial cell density (cells/mm²) measured by specular microscopy.

Time frame
1 month
3

Mean anterior chamber cell grade

Mean grade of anterior chamber cells according to Standardization of Uveitis Nomenclature (SUN) criteria.

Time frame
1 week
4

Incidence of postoperative corneal edema

Proportion of eyes with clinically significant postoperative corneal edema.

Time frame
1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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