The effects on the density of corneal endothelial cells from the use of intracameral Levofloxacin 0.5% versus 1.5% in cataract patients undergoing surgical treatment.

The effects on the density of corneal endothelial cells from the use of intracameral Levofloxacin 0.5% versus 1.5% in cataract patients undergoing surgical treatment : A Double-blinded Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250919001

Enrollment

Registered

2025-09-19

Start date

2025-09-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety of intracameral levofloxacin 1.5% in cataract patients undergoing phacoemulsification surgery Levofloxacin, Intracameral, Cataract Extraction, Phacoemulsification Corneal Endothelium Density

Interventions

Patients will receive 0.1 mL of intracameral levofloxacin 1.5% injected into the anterior chamber at the end of phacoemulsification surgery.,Patients will receive 0.1 mL of intracameral levofloxacin 0

Experimental Drug,Active Comparator Drug

Intracameral Levofloxacin 1.5%,Intracameral Levofloxacin 0.5%

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged over 18 years. 2. Diagnosed with cataract according to the Lens Opacities Classification System III, grade NO2NC2 to NO4NC4. 3. Preoperative corneal endothelial cell density greater than 1800 cells/mm2

Exclusion criteria

Exclusion criteria: 1. Presence of other ocular pathologies such as corneal dystrophy, glaucoma, retinal diseases, or uveal diseases. 2. History of corneal infection (keratitis). 3. Previous intraocular surgery. 4. History of ocular trauma. 5. Known allergy to quinolones.

Design outcomes

Primary

Measure	Time frame
Change in corneal endothelial cell density Baseline (pre-op) and 3 months postoperatively Measured by specular microscopy	—

Secondary

Measure	Time frame
Change in central corneal thickness Baseline (pre-op) and 3 months postoperatively Measured by corneal pachymetry,Best corrected visual acuity Baseline (pre-op) and 3 months postoperatively Measured with Snellen chart, converted to logMAR,Anterior chamber inflammation Post-operation day 1, week 1, month 1 Measured by slit-lamp biomicroscopy, graded using Standardization of Uveitis Nomenclature criteria	—

Measure

Time frame

Change in central corneal thickness Baseline (pre-op) and 3 months postoperatively Measured by corneal pachymetry,Best corrected visual acuity Baseline (pre-op) and 3 months postoperatively Measured with Snellen chart, converted to logMAR,Anterior chamber inflammation Post-operation day 1, week 1, month 1 Measured by slit-lamp biomicroscopy, graded using Standardization of Uveitis Nomenclature criteria

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Countries

Thailand

Contacts

Public ContactTharit Harndamrong

Bhumibol Adulyadej Hospital

winsurf2610@gmail.com0854455966

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026