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Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis

Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis: A phase I randomized clinical trial (RCT) study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130812014333N216
Enrollment
12
Registered
2024-05-10
Start date
2024-05-21
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Corneal ulcer. Corneal ulcer

Interventions

Intervention 1: In the intervention group, after dropping a 0.5% tetracaine drop (Sinadaro, Tehran, Iran) in the eye with a corneal ulcer, a nanofiber containing vancomycin-amikacin is placed in the l

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 18 years Bacterial corneal ulcer with high clinical suspicion Wound size greater than 2 mm BCVA greater than 200/20 in the uninvolved eye

Exclusion criteria

Exclusion criteria: Patients with uncontrolled diabetes Corneal perforation or its imminent Symptoms of inflammation in both eyes History of glaucoma shunt or filtering surgery Pregnant or lactating women History of corneal surgery due to refractive errors

Design outcomes

Primary

MeasureTime frame
Reducing the healing time of corneal wounds. Timepoint: every 2 hours on days 3 to 6, every 2 hours when waking up on days 7 to 9, every 6 hours on day 9 and continue treatment until the wound heals. Method of measurement: Based on slit lamp examination with corneal fluorescein staining.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahla Mirzaeei

Kermanshah University of Medical Sciences

smirzaeei@kums.ac.ir+98 83 3427 6489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026