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Treatment of vernal keratoconjunctivitis a double-masked study
L Gradstein1, N Matamoros, E Cohen
1Pediatric and Immuno Ophthalmology Unit, Department of Ophthalmology, Hadassah University Hospital, Jerusalem, Israel.
Insights
Fluorometholone 0.1% (FML) eye drops effectively treated severe vernal keratoconjunctivitis (VKC) in children, showing significant improvement compared to cromolyn sodium and artificial tears. Cromolyn sodium offered no significant advantage over artificial tears for VKC symptom relief.
Area of Science:
- Ophthalmology
- Allergy and Immunology
Background:
- Vernal keratoconjunctivitis (VKC) is a severe allergic eye condition affecting children.
- Effective management of VKC is crucial to prevent vision-threatening complications.
Purpose of the Study:
- To compare the efficacy of fluorometholone 0.1% (FML), cromolyn sodium 2%, and artificial tears in treating severe pediatric VKC.
- To assess the safety and tolerability of these ophthalmic preparations.
Main Methods:
- A double-masked, randomized study involving 31 children (aged 5-14) with severe VKC.
- Objective assessment of disease activity using a standardized five-point scale under slit lamp examination.
- Statistical analysis using the chi-square test to compare treatment outcomes.
Main Results:
- Fluorometholone 0.1% (FML) demonstrated statistically significant efficacy in treating severe VKC compared to both cromolyn sodium and artificial tears (p=0.05 and p=0.005).
- Cromolyn sodium 2% showed no statistically significant difference in efficacy compared to artificial tears.
- All treatments were generally well-tolerated, though one patient developed allergic blepharitis with FML, and another developed posterior subcapsular cataract after long-term corticosteroid use.
Conclusions:
- Fluorometholone 0.1% is a highly effective treatment for severe vernal keratoconjunctivitis in children.
- Cromolyn sodium 2% and artificial tears showed comparable, less effective outcomes for severe VKC in this study.
- While effective, potential side effects of FML and long-term corticosteroid use warrant careful monitoring.
Abstract:
Thirty-one children aged five to 14 years with severe vernal keratoconjunctivitis (VKC) were enrolled in a double-masked study evaluating the efficacy of three ophthalmic preparations: cromolyn sodium (Opticrom) 2%, artificial tears and fluorometholone 0.1% (FML). These drugs were coded respectively as A, B, C, and dispensed in similar bottles. Both eyes were treated, and drug assignment was made at random. Objective assessment of the disease activity was done under slit lamp by two ophthalmologists according to a five-point scale. The results were tabulated and the chi-square test performed. Decoding of the drugs was done only after completion of the statistical analysis. FML was found effective with a statistically significant difference from the other two drugs, both after the first week on the initially assigned treatment (p = 0.05) and on completion of the treatment period according to protocol (p = 0.005). Although several patients improved under cromolyn sodium, there was no statistically significant difference between cromolyn sodium 2% and artificial tears. All the preparations were well tolerated. One patient developed bilateral allergic blepharitis when treated with FML during the study. Another patient who responded well to FML developed posterior subcapsular cataract while continuing treatment with corticosteroids a few months after completion of the study.
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