Randomized Controlled Trial Of Two Kinds Of Fluorescein Sodium Ophthalmic Strip To The Diagnosis Of Corneal Injury

Objective:To evaluate the effectiveness,comfort and safety of a new kind of Fluorescein Sodium Ophthalmic Strip in the the diagnosis of corneal injury by comparing with the the gold standard Fluorescein Sodium Ophthalmic Strip.Methods:This study protocol followed the Declaration of Helsinki,and oral informed consent was obtained from each patient prior to entering the cohort.Randomized,cross-matched clinical trial was conducted.Total 84 patients with corneal disease were enrolled in Second affiliated hospital of anhui medical university from November 2017 to December 2017.Each subject received test strips of test group or control group in a random orderobservation patient’s test results and adverse reactions,including effectiveness(corneal fluorescence staining grading,position),comfort(Subjects comfort score after contact with stain),security(conjunctival congestion and corneal edema classification).Results In this study,84 cases were enrolled,168 eyes,of which 19,16,17,17 and 15 were classified as grade 0,1,2,3 and 4 corneal injuries(subject staining grading according to the high degree of injury),and the number of eyes were 91,22,23,17 and 15 respectively.The consistency was excellent for corneal fluorescence staining grading,position(Kappa = 0.973,0.989,P < 0.01),There was a statistically significant difference in the degree of comfort between subjects(P<0.05).There was no change in conjunctival hyperemia and corneal edema between the two test strips before staining and after staining,and no serious adverse events occurred.Conclusion: 1.Fluorescence ophthalmic test paper in the experimental group could effectively detect the corneal epithelial defect,display the lesion location,range and preliminary depth of judgment;2.Both of the two kinds of fluorescein sodium detection paper have high safety in corneal staining and low toxicity on the conjunctiva.3.Compared with similar products on the market in China,the fluorescein sodium ophthalmic test paper in the experimental group has the same effectiveness and safety in the examination of corneal structural injury,and has a higher comfort level.