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Not yet recruitingNCT07850414Updated Sep 30, 2026

Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery

An interventional study of Levofloxacin and Moxifloxacin in Cataract and Postoperative Endophthalmitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Postoperative endophthalmitis is a serious complication of cataract surgery. Intracameral antibiotics are used to reduce this risk.

This study will randomly assign patients undergoing elective phacoemulsification to receive either intracameral levofloxacin, intracameral moxifloxacin, or no intracameral antibiotic (control). Patients will be followed for visual outcomes, anterior chamber inflammation, and corneal endothelial safety.

02

Conditions studied

  • Cataract
  • Postoperative Endophthalmitis

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Keywords

  • Intracameral antibiotic
  • Cataract surgery
  • Levofloxacin
  • Moxifloxacin
  • Assiut
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • - 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
  • Willing and able to attend scheduled postoperative follow-up visits

Exclusion criteria

Exclusion Criteria:

  • - 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    Intracameral Levofloxacin

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

    Drug: Levofloxacin

  • Active comparator
    Intracameral Moxifloxacin

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

    Drug: Moxifloxacin

  • No intervention
    No Intracameral Antibiotic

    Patients will undergo standard phacoemulsification without any intracameral antibiotic injection.

Interventions

  • DrugLevofloxacin

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

  • DrugMoxifloxacin

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

05

What researchers measure

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

  5. Mean central corneal thickness

    Mean central corneal thickness in micrometers.

    Time frame: 1 month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07850414
Lead sponsor
Assiut University
Responsible party
Sherly Shamoun (Resident Physician, Department of Ophthalmology, Assiut University) — Principal investigator
First posted
Sep 30, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Feb 25, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Sherly S Sobhy, Resident
Contact
Sherly.21413@gmail.com
01281224292
Mohamed s Abdel rahman, prof
study chair · Ophthalmology Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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