Bacterial Keratitis, Corneal Ulcer, Recalcitrant Infectious Keratitis
Conditions
Brief summary
Bacterial keratitis is a potentially sight-threatening corneal infection that is commonly treated with intensive topical antibiotics. Despite appropriate therapy, some cases show inadequate clinical response, particularly when the infection involves the deep corneal stroma. Limited penetration of topical antibiotics into deeper corneal layers may contribute to treatment failure in these recalcitrant cases. Intrastromal antibiotic injection is a targeted drug-delivery approach that allows high local antimicrobial concentrations directly at the site of infection. Moxifloxacin is a broad-spectrum fluoroquinolone with proven efficacy in bacterial keratitis and favorable corneal tissue penetration. However, evidence regarding the clinical benefit and safety of intrastromal moxifloxacin as an adjunctive treatment remains limited. This randomized controlled trial aims to evaluate the efficacy and safety of intrastromal moxifloxacin injection as an adjunct to standard topical moxifloxacin therapy compared with topical therapy alone in patients with recalcitrant bacterial keratitis. The primary outcome is time to complete clinical resolution of infection. Secondary outcomes include visual acuity improvement, ulcer healing rate, need for additional interventions, and treatment-related complications.
Interventions
DRUGIntrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
DRUGStandard topical moxifloxacin therapy alone
Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization will be performed using a computer-generated random sequence. Allocation will be concealed using sealed opaque envelopes.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Age ≥ 18 years * Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology * Recalcitrant keratitis defined as no significant clinical improvement after 48-72 hours of intensive topical antibiotic therapy * Ability to provide written informed consent
Exclusion criteria
* Fungal, viral, or acanthamoeba keratitis * Corneal perforation or impending perforation * Known hypersensitivity to fluoroquinolones * Pregnancy or lactation * Immunocompromised state or current systemic immunosuppressive therapy * Previous intrastromal or intracameral antibiotic injection for the same episode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete clinical resolution(days) | weekly till complete healing | Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Epithelial defect size(mm) | weekly for one month | epithelial defect is measured by surgical caliper |
| Hypopyon height(mm). | weekly for one month | — |
| Pain score on visual Analog scale (VAS, 1 - 10). | weekly for one month | — |
| Best-corrected visual acuity (BCVA) (LogMAR or Snellen) | weekly for one month | — |
| Complications (perforation, thinning, endophthalmitis). | after 3 months | — |
Countries
Egypt
Contacts
CONTACTMahmoud Ramadan Amer, MD
Outcome results
None listed