A randomized controlled clinical trial of the effectiveness and safety between aspherical and NUV soft hydrophilic contact lenses for myopia patients / 中华实验眼科杂志

ABSTRACT

Background The clinical effectiveness of soft corneal contact lens for correction of myopia has been confirmed.Theoretically,aspherical soft hydrophilic corneal contact lens has better visual qualify for myopic eyes,and the lenses have been applied widely.But abnormal tear film,even many cornea and conjuctiva diseases caused by soft contact lens have been reported,so the effectiveness and safety of aspherical soft hydrophilic corneal contact lens are worth concerning.Objective This clinical trail was to compare the effectiveness and safety between aspherical and NUV soft hydrophilic contact lens for myopic eyes.Methods A randomized,double-blind and controlled clinical study was performed under the approval of Ethic Committee of Qingdao Municipal Hospital and informed consent of each patient.One hundred and forty eyes of 70 myopic patients were enrolled in QingdaoMunicipal Hospital from July to October,2012.The subjects were randomized into the trial group and control group using random number table.Aspherical soft hydrophilic contact lenses were worn in the trial group and NUV soft hydrophilic contact lenses were worn in the control group.The characteristics of the lens surface,outcomes and the eye number in different scores of ocular signs and symptoms were assessed before and 15 minutes,1 week,2 weeks and 1 month after wearing lenses.Results The sores of humidity of anterior surface,the sediment in anterior and posterior surface are 0 in both lenses in various time points after wearing.The corrected visual acuity of all the subjects were ≥ 1.0.The eye number of 2-3 scores in various ocular signs was 0 in both groups,but the eye number of 1 score in palpebral conjunctival congestion and limbus congestion were more in the trail group than those in the control group in different time points (all at P＜0.05).There were significant differences in corneal fluorescine staining between the groups in different time points (all at P＞0.05).There was no eye for 2-3 scores of eye symptoms in both groups.The eye number for 1 score in foreign body sensation increased in the target-trail group compared to the control group at various time points (P =0.002,0.006,0.005,0.005).However,there was no statistically significant differences in the eye number for 1 score in visual clearness and stability between the two groups at the follow-up duration (all at P＞ 0.05).Conclusions Aspherical soft hydrophilic corneal contact lens has good outcomes in corrected visual acuity for myopia like NUV soft hydrophilic contact lens,but the wearing of aspherical soft hydrophilic corneal contact lens induces more ocular discomfortableness.