Infective Keratitis
Conditions
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
Interventions
PROCEDURECorneal Collagen Cross-Linking Solutions
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 which riboflavin was instilled every 2 min and corneal pachymetry performed every 5 min. PACK-CXL was performed in a 9
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.
Sponsors
Research Institute of Ophthalmology, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Methods Study Design: A prospective, single centre, randomised controlled study of forty eyes of forty patients was conducted. The study was approved by local institutional review board (Approval number 109) and adhered to the Declaration of Helsinki. All patients provided informed consent before enrolling and participating in the study. Selection: All patients presenting with infective keratitis were explained about the study and informed consent was sought (CONSORT Diagram). Fifty-three patients were screened against the exclusion criteria and 13 were excluded. The remaining total of 40 patients were allocated equally to two groups (A and B) by process of simple randomisation. 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
• Patients presenting with infectious keratitis
Exclusion criteria
* Infective keratitis \< 1mm from limbus * Corneal thickness \< 350μm * Previous herpetic eye disease * Expectant and nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed