NCT07850414

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

September 24, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2028

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

CataractPostoperative Endophthalmitis

Keywords

Intracameral antibioticCataract surgeryLevofloxacinMoxifloxacinAssiut

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative endophthalmitis

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

    1 month

Secondary Outcomes (5)

  • Mean best-corrected visual acuity

    1 month

  • Mean endothelial cell density

    1 month

  • Mean anterior chamber cell grade

    1 week

  • Incidence of postoperative corneal edema

    1 week

  • Mean central corneal thickness

    1 month

Study Arms (3)

Intracameral Levofloxacin

EXPERIMENTAL

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

Drug: Levofloxacin

Intracameral Moxifloxacin

ACTIVE COMPARATOR

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 Intracameral Antibiotic

NO INTERVENTION

Patients will undergo standard phacoemulsification without any intracameral antibiotic injection.

Interventions

LevofloxacinDRUG

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

Intracameral Levofloxacin
MoxifloxacinDRUG

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

Intracameral Moxifloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

LevofloxacinMoxifloxacin

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mohamed s Abdel rahman, prof

    Ophthalmology Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Sherly S Sobhy, Resident

CONTACT

01281224292Sherly.21413@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Ophthalmology

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

February 25, 2028

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share