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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
Mahmoud Ramadan Amer
Minya, Egypt
RECRUITINGTime to complete clinical resolution(days)
Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.
Time frame: weekly till complete healing
• Epithelial defect size(mm)
epithelial defect is measured by surgical caliper
Time frame: weekly for one month
Hypopyon height(mm).
Time frame: weekly for one month
Pain score on visual Analog scale (VAS, 1 - 10).
Time frame: weekly for one month
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)
Time frame: weekly for one month
Complications (perforation, thinning, endophthalmitis).
Time frame: after 3 months
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