The clinical efficacy and safety study of Esculin and Digitalis glycosides Eye Drops in treating ametropic asthenopia

Objective To study the clinical efficacy and safety of the Esculin and Digitalisglycosides Eye Drops used in the patients of ametropic asthenopia. Methods Multicenter clinical trial. Asthenopia patients were chosen from eleven hospitals cross China from July, 2008 to January, 2009.The experiment was conducted asthenopia patients who used the Esculin and Digitalisglycosides Eye Drops for 4 weeks continuously. Symptoms of asthenopia, UCVA (uncorrected vision acuity ), refraction,amplitude of accommodation, accommodative lag, accommodative sensitivity and positive/negative relative accommodation were measured at different time points, such as treated before, 1 week and 4 week in treated after. Results After the 4-week's use of Esculin and Digitalisglycosides Eye Drops, each subjective symptom of the patients was decreased significantly ( F = 353.30, P ＜ 0. 05 ). In addition, most of the objective exams of accommodation ability were significantly improved, such as UCVA ( left eye: F = 23. 39,P ＜ 0. 05; right eye: F = 15.62, P ＜ 0. 05 ), refraction ( left eye: F = 10. 34, P ＜ 0. 05; right eye: F =17. 13 ,P ＜ 0. 05 ), amplitude of accommodation ( left eye: F = 14.46, P ＜ 0. 05; right eye: F = 8. 29, P ＜0. 05 ;eyes: F = 13.86, P ＜ 0. 05 ), accommodative lag ( F = 14. 89, P ＜ 0. 05 ) and accommodative sensitivity ( left eye: F = 62. 67, P ＜ 0. 05; right eye: F = 68. 77, P ＜ 0. 05; eyes: F = 82.74, P ＜ 0. 05 ).And no patient appeared any adverse reaction in whole experiment. Conclusions Esculin and Digitalisglycosides Eye Drops is effective and safety for use in the patients of ametropia asthenopia. Key words: Esculin;  Digitalis glycosides;  Refractive errors;  Asthenopia