Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy, Standard topical moxifloxacin therapy alone.
- Who it may be relevant to
- Registry conditions: Bacterial Keratitis, Recalcitrant Infectious Keratitis, Corneal Ulcer. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions. - Drug Standard topical moxifloxacin therapy alone
Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
Primary outcome measures
- Time to complete clinical resolution(days) [Time frame: weekly till complete healing]
Secondary outcome measures (5)
- • Epithelial defect size(mm) [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Mahmoud Ramadan Amer — Minya
Publications
- Zemba M, Radu M, Istrate S, Dumitrescu OM, Ionescu MA, Vatafu A, Barac IR. Intrastromal Injections in the Management of Infectious Keratitis. Pharmaceutics. 2023 Mar 29;15(4):1091. doi: 10.3390/pharmaceutics15041091. PMID 37111577
Identifiers
NCT: NCT07394257 · 1827