Efficacy, Fluconazole, Fungal Keratitis, Intrastromal Injection, Safety, Treatment
Conditions
Brief summary
This study aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis.
Detailed description
Fungal keratitis is one of the most challenging types of infectious keratitis. It now accounts for approximately 50% of infectious corneal diseases, and corneal blindness has become the second leading cause of blindness in developing countries. The potentially poor prognosis may be due to a delay in diagnosis and / or to limited effective antifungal agents that leads to decrease visual acuity and blindness. Fluconazole is mainly a fungistatic drug with broad spectrum activity as it is effective against Yeast & Dermatophytes (Candida, Cryptococcus neoformans & Aspergillus species) Fluconazole is stable and a water-soluble small molecule with high bioavailability and low toxicity.
Interventions
DRUGTopical fluconazole eye drops
Eyes that received treatment as topical fluconazole eye drops
DRUGIntrastromal injection of fluconazole
Eyes that received treatment as intrastromal injection of fluconazole.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed both clinically and laboratory as fungal keratitis. * Fungal cultures should be sensitive to fluconazole.
Exclusion criteria
* Thin cornea. * Decmatocele. * Necrotic or perforated corneal ulcers. * Other types of keratitis (bacterial or viral). * Fungal cultures resistant to fluconazole. * Patients on immune-suppressants drugs. * Silicon oil filled eyes. * Previous ocular surgery e.g keratoplasty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity | Every three days until complete healing (Up to 6 weeks) | Best-corrected visual acuity (BCVA) was recorded and described by LogMAR notation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected visual acuity | Every three days until complete healing (Up to 6 weeks) | Uncorrected visual acuity was recorded and described by LogMAR notation. |
| Duration of healing | 6 weeks post-procedure | Duration of healing was recorded. |
Countries
Egypt
Outcome results
None listed