ABSTRACT
Objective:To evaluate and compare the clinical efficacy and safety of three different medicated eye patches in the treatment of Demodex blepharitis. Methods:A multicenter, randomized, double-blind, parallel-controlled clinical trial was conducted.A total of 140 patients (280 eyes) with Demodex blepharitis were recruited in Shanghai Jing'an District Shibei Hospital, Xi'an Fourth Hospital and Kunming First People's Hospital from July 2021 to December 2022.The affected eyes were randomly divided into tea tree oil group, okra oil group, basal fluid control group and metronidazole group by the random number table method.Eye patches containing 20% tea tree oil, 1% okra oil, prepared base solution and 2% metronidazole were applied to the eyes for 28 days by the double-blind method.The count of Demodex was evaluated before treatment and on days 14 and 28 of treatment.Ocular surface symptoms were scored according to Ocular Surface Disease Index (OSDI). The degree of congestion at the eyelid margin and cylindrical dandruff at the root of eyelashes were scored under a slit lamp microscope.The effective rate was calculated according to the comprehensive scores above, and the adverse reactions of the subjects were observed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Shanghai Jing'an District Shibei Hospital (No.YL-20200320-05). All the subjects were informed of the significance, purpose and method of the study.Written informed consent was obtained from each subject before any medical examination. Results:All subjects completed the treatment and follow-up, and the loss to follow-up rate was 0%.After 14 and 28 days of treatment, the Demodex count was significantly decreased in all groups compared with before treatment (all at P<0.05). After 28 days of treatment, the number of Demodex in tea tree oil group, okra oil group and metronidazole group were significantly lower than that in basal fluid control group, with statistically significant differences (all at P<0.05). The OSDI score, palpebral margin congestion score and cylindrical dandruff score on 14 and 28 days after treatment in tea tree oil group, okra oil group and metronidazole group were significantly lower than before treatment, showing statistically significant differences (all at P<0.05). After 28 days of treatment, the effective rates of tea tree oil group, okra oil group and metronidazole group were 71.4%, 71.4% and 62.9%, respectively, which were significantly higher than 25.7% in basal solution control group.No serious local or systemic adverse reactions were found during the treatment and follow-up. Conclusions:Eye patches containing tea tree oil, okra oil and metronidazole have significant effects on the treatment of Demodex blepharitis, which can improve the biological environment of the palpebral margin and eliminate the inflammation related to blepharitis.
ABSTRACT
Background It has been reported that orthokeratology has the effects of slowing down myopia progression and axial elongation.However,the affecting mechanism of orthokeratology wearing on ocular peripheral refraction is still not elucidated.Objective This study was to observe and compare the changes of ocular peripheral refraction and relative peripheral refraction (RPR) in low to moderate myopic eyes of children after wearing orthokeratology lens and spectacles for 6 months.Methods A randomized controlled clinical trial was carried out after approval of Ethic Committee of Beijing Tongren Hospital and informed consent of guardians of the children.One hundred myopic children aged (ll.0±1.9) years were recruited in Beijing Tongren Hospital from June 2014 to January 2015,with the diopter of-0.50 to-6.00 D.The subjects were randomized into orthokeratology group and spectacles group by the process PLAN PROC of software SAS 9.1.3,50 for each group.The subjects in the orthokeratology group wore orthokeratology lens for 6 months and those in the spectacles group wore spectacles for the same period.An infrared open-field autorefractor was employed to measure the refraction at central 0°,temporal 15°,temporal 30°,nasal 15°and nasal 30° radial lines before and after wearing lens for the assessment and comparison of the changes of peripheral refraction and RPR.Results There was no significant difference in spherical equivalent between the orthokeratology group and the spectacles group before wearing lens ([-3.35±1.31] D versus [-3.01± 1.15] D,P =0.20).The peripheral refraction values in the orthokeratology group were (-2.28 ± 1.60),(-3.28±1.41),(-3.40±1.23),(-3.38±1.12) and (-2.09±1.29)D at nasal 15°and nasal30°,central,temporal 15° and temporal 30°radial lines before wearing lens,and reduced by (0.29±1.67),(0.85±1.66),(0.92±1.76) and (0.66±1.66) D at nasal 30°,nasal 15°,central and temporal 15° after wearing lens,respectively,with significant differences at nasal 15°,central and temporal 15°(all at P＜0.05).The peripheral refraction values in the spectacles group were (-1.88±1.30),(-2.66±1.18),(-2.89±1.27) and (-1.94±1.31)D at nasal 15°,nasal 30°,temporal 15 ° and temporal 30°,radial lines before wearing lens and increased by (-0.25±0.80),(-0.43 ±0.67),(-0.32±0.64) and (-0.22±0.75)D after wearing lens,respectively,with significant differences between before and after wearing lens (all at P＜0.05).The RPR shifted from hyperopia defocus to myopia defocus before and after wearing lens in temporal 15° and 30° radial lines in the orthokeratology group,and at various radial lines in the spectacles group,the RPR showed gradually worsening of hyperopia defocus.Conclusions Long-term wearing of orthokeratology results in a hyperopia shifting in myopic children by exposing the peripheral retina towards relative myopia defocus,whereas wearing spectacles leads to a relative hyperopia defocus on retina.Thus,orthokeratology may slow down the myopia progression.
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.