The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis
- Conditions
- Infective Keratitis
- Interventions
- Drug: Topical Antimicrobial/Antifungal MedicationsProcedure: Corneal Collagen Cross-Linking Solutions
- Registration Number
- NCT06967376
- Lead Sponsor
- Research Institute of Ophthalmology, Egypt
- Brief Summary
This was a prospective, single centre, randomised controlled study to evaluate the clinical effectiveness of corneal collagen crosslinking as an adjuvant to antimicrobial therapy.
- Detailed Description
This randomised controlled study of forty eyes of forty patients was conducted to assess the impact of corneal collagen crosslinking in addition to antimicrobial therapy.
All forty patients presenting with infective keratitis of various aetiologies (bacterial, fungal, acanthamoeba) were screened and then randomly allocated equally to two groups (A and B). Group A patients were to be offered standard targeted anti-microbial therapy whilst group B were offered CXL in addition to the standard targeted anti-microbial therapy.
Patients were evaluated clinically for visual acuity; infection parameters and dimensions were measured on slit lamp and optical coherence tomography. Evaluations were noted at the baseline visit and subsequently on days 7, 14, and day 30 of treatment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
• Patients presenting with infectious keratitis
- Infective keratitis < 1mm from limbus
- Corneal thickness < 350μm
- Previous herpetic eye disease
- Expectant and nursing women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm that take medical treatment only for infective keratitis Topical Antimicrobial/Antifungal Medications On presentation, all pre-existing treatment was stopped for 48 hours and corneal scrapes for direct smears and cultures using blood agar, chocolate agar, thioglycolate broth and sabouraud dextrose agar were done. Initial antimicrobial therapy for both groups consisted of fortified vancomycin eye drops 50 mg/ml, fortified ceftazidime eye drops 50 mg/ml hourly, and the antifungal agent itraconazole 100 mg orally twice per day. This regimen was subject to change according to microbiology culture sensitivities and/or results. Arm of patients take cross linking as an adjuvant treatment to medical treatment Corneal Collagen Cross-Linking Solutions Patients allocated to the PACK-CXL group were assessed and treated by PACK-CXL within 2 days of treatment initiation. Topical anaesthesia was achieved using 0.4% benoxinate hydrochloride drops. Epithelium was removed up to 9 mm diameter. Corneal thickness of the area to be treated was measured (without epithelium) aiming for a starting thickness of no less than 350μm. Corneas thicker than 500μm were dehydrated to reduce thickness by using 70% Glycerol drops applied topically at intervals of 2-3 seconds for a total of five minutes. A schematic representation of PACK-CXL protocol is provided in Figure 1. Iso-osmolar riboflavin drops were instilled topically on the cornea at regular intervals of 2 minutes for a total period of 30 minutes. Thickness was also re-measured every 5 min to ensure that it remained below 500µm during instillation of riboflavin. The cornea was illuminated using a UVX, UV-A 365 nm with an irradiance of 3 mW/cm2 for 30 minutes and a total dose of 5.4 J/cm2 during
- Primary Outcome Measures
Name Time Method clinical response At presentation; and then on day 7, day 14 and day 30 of commencing treatment Ulcer dimensions will be studied on slit lamp and AS-OCT.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Institute of Ophthalmology
🇪🇬Giza, Egypt