| Part1:Study on the safety and effectiveness of personalizedOrthokeratology for controlling myopia in adolescents.Purpose:To analyze the variation for observable indices which include the naked eye vision,the corrected visual acuity,the axial length of the eye,the incidence of various complications,corneal endothelial cells,the tear function,the corneal curvature,the central corneal thickness,the contrast sensitivity,the aberrations,corneal biomechanics and other observations in myopia patients after night-wearing Orthokeratology contact lenses(OK),also to evaluate the short-time as well as long-term safety and effectiveness of personalized Orthokeratology myopia in adolescents.Methods:Using prospective,randomized and controlled trials,100 patients(total 180 eyes)were selected from the outpatient department of Shenzhen Children’s Hospital.The Orthokeratology inclusive standard is:age 8 to 18 years old,except for refractive errors,no other diseases of the eye and Systemic immune system diseases,preoperative corneal topography exclusion of keratoconus lesions,intraocular pressure≤21mmHg;myopia spherical degree-0.75~-6.00D;cylinder degree-0.25~-3.00D,corneal astigmatism≤-1.50 D recommended for patients 4 The shaping mirror of the ordinary spherical surface in the arc area,the corneal astigmatism>-1.50 D patients choose parallel arc for Toric design(personalized design according to corneal topography),and the other 3 arc area spherical design shaping mirror.The comparative analysis performed before wearing OK lens and wearing OK lens1 day,1 week,1 month,3 months,6 months,1 year,2 years is to observe and compare naked eye vision,diopter,axial axis,best corrected visual acuity,intraocular pressure,wearer’s subjective symptoms,central corneal thickness,the number of corneal endothelial cell,the corneal viscous coefficient value,the K value of corneal topographic map and the incidence of complications after wearing OK lens.The statistical analysis using SPSS13.0 software package to compare the data before and after wearing OK lens including t test,paired t test and chi-square X~2.The detection level was P=0.05 while P<0.05 indicates the difference is of statistical significance.Results:1,The wearer’s naked eye and corrected visual acuity improved significantly after wearing the mirror the next day,and the diopter decline changed significantly.After 6months,100 cases of 180 eyes with uncorrected visual acuity 20/20 accounted for 161eyes(89.5%),corrected visual acuity 20/20 accounted for 100%,naked eye vision was20/32 for 5 eyes(2.7%),and naked eyesight 20/25 14 eyes(7.8%);the difference was statistically significant(P<0.01);the diopter(spherical and lenticular)were decreased after wearing for 6 months,the difference was statistically significant(P<0.01).There was no significant difference in the corrected visual acuity before and after wearing(P>0.05).There was no obvious abnormality in the axial axis,and the difference was not statistically significant(P>0.05).After 6 months of Orthokeratology,the visual acuity and diopter of the naked eye were in a stable state.The visual acuity of the naked eye increased from 6 months to 1.5 years.The diopter(spherical mirror,lenticule)fell to the baseline after 6 months to 1.5 years,achieving complete correction.effect.2,1 day after wearing the lens,1 week,wearing the mirror 6 months,1year,2years after the 5mm optical zone level K1 and vertical K2 decreased,the difference was statistically significant(P<0.01).Wearing a mirror for 3 months,the corneal shape was stable,and there was no significant change in the corneal topography after long-term follow-up of 2 years.3,before wearing glasses and long-term follow-up after wearing glasses for 2 years to observe the biological parameters found:central corneal thickness,corneal endothelial cell count,anterior chamber depth,tear function test,intraocular pressure changes were not obvious,the difference was not statistically significant(P>0.05).4,the best corrected visual acuity after wearing the lens for 6 months is better than before wearing the lens,P value=0.08,the difference is not statistically significant;when the contrast is 20%,40%,60%,the visual acuity of 6mo after wearing the lens is0.83±0.08,respectively.0.96±0.09,0.99±0.15;before the wearing of 0.85±0.11,0.96±0.11,0.99±0.11,respectively,the P value was greater than 0.05,the difference was not statistically significant.5,When the pupil is 6.0mm,before wearing the lens(P1=2.77±0.79,P2=0.59±0.27,P3=0.50±0.22);after wearing the lens(P1=2.36±0.22,P2=0.66±0.48,P3=0.61)±0.43)The coma and high-order aberrations before wearing the lens were smaller than the 6 months aberration after wearing the lens,but the P value was greater than 0.05,and there was no significant difference.The total aberration was greater than 6 months after wearing the lens,and the difference was not statistically significant.6,corneal hysteresis(corneal hysteresis CH),before wearing glasses and 1 day,1week after wearing glasses,CH,CH decreased,PCH1=0.02,PCH2=0.021,the difference was statistically significant,6 months to 2 years after wearing the lens basic In the stable phase,the P value was greater than 0.05,and the difference was not statistically significant.7,wearer comfort subjective survey:comprehensive satisfaction:good accounted for55.4%,basic good accounted for 44.6%;fit feeling:good accounted for 20.1%,basic good accounted for 79.9%;visual clarity:good for 32.2%,The basic good is 67.8%.8,Fluorescent staining showed 19 eyes(10.56%)with occasional punctate cornea staining.After stopping for 2 days,after giving sodium hyaluronate eye drops and ofloxacin eye drops(Japanese ginseng),the symptoms disappeared and continued to wear mirror;3 eyes(1.67%)see denser corneal staining,the symptoms did not improve significantly after treatment,the examination found that both eyes under the palpebral palpebral palpebral,sputum wear,it is recommended to wear lower eyelid varus correction surgery,158 eyes(87.77%)no corneal staining;5 eyes(2.78%)bulbar conjunctiva slightly confined to one quadrant,175 eyes(97.22%)conjunctival no hyperemia;10 eyes(5.56%)睑conjunctival vascular dilatation with hyperemia,smooth surface Degree drops.170 eyes(94,44%)had no obvious hyperemia in the conjunctiva.Conclusions:1,Personalized Orthokeratology is one of the safe and effective methods for treating myopia for adolescents.2,Through the corneal topography to guide the individualized fitting and matching technology,compare and analyze the corneal biological parameters before and after wearing the lens for 1 day,1 week,1 month,3 months,6 months,1 year,2 years,clinically it is further confirmed that personalized Orthokeratology can change the curvature of the cornea,reduce the diopter,improve the naked eye vision of patients with myopia,and provide important reference indicators for the establishment of the prevention and control big data model of adolescent myopia.It also provide evidence for further standardizing the fitting of Orthokeratology and provide reference data for the optimization and improvement of the Ortho-K contact lenses.Part2:Comparative study of personalized Orthokeratology and wearing frame glasses for treating myopia in adolescents Purpose: By comparing and analyzing the eye axis and diopter growth of children with myopia wearing Orthokeratology group(OK group)and wearing frame glasses group,the clinical significance of personalized Orthokeratology to control myopia in teenagers was discussed.Methods: Using prospective and two-group control design,84 patients from the ophthalmology outpatients in Shenzhen Children’s hospital were selected.They were divided into Orthokeratology group(40 cases)and frame glasses group(44 cases)according to their wishes.The data of this study were taken right eye.The Orthokeratology group inclusion standard is same as that from part 1.Frame glasses group inclusion criteria is: age from 8 to 18 years old,in addition to refractive error,no other diseases of the eye and systemic immune system diseases,preoperative corneal topographic examination excluded keratoconus lesions,intraocular pressure <21mm Hg;myopia spherical degree-0.75 ~-6.00D;cylindrical mirror degree-0.25 ~-2.00D.Comparative analysis is performed for 1 year,2 years for the diopter and the axial length changes before wearing glasses,OK lens group and frame glasses group.Statistical analysis was performed using the SPSS13.0 software package.The characteristic difference between the two groups was analyzed by t test or X2 test.The LSD-t test was used to compare the two groups.Statistical analysis was performed on the data.The detected level was P=0.05 while P<0.05 is considered statistically significant.Results: 1,Differences in characteristic data(age,gender,height,volume,horizontal corneal refractive power,diopter)between the OK lens group and the frame glasses group before wearing glasses were not statistically insignificant(P>0.05);The difference in axial length was not statistically significant(P>0.05).2,In the first year of the OK lens group,the diopter increased by 0.11±0.01 D on average,and the average increase in the second year was 0.10±0.02 D.The two-year average was compared,and the P value was greater than 0.05.The difference was not statistically significant.The annual myopia degree only increased by 0.10 D.The increase of about 0.20 D in two years;the frame glasses group,the average diopter increased by 0.33±0.11 D in the first year,and the average increase of 0.31±0.12 D in the second year.The two-year average was compared,the P value was greater than 0.05,the difference was not statistically significant,myopia The degree increased by about 0.44 D in a few years and nearly 0.84 D in two years.Compared with the frame glasses group,the P-value was less than 0.05,and the difference was statistically significant.3,In the first year of wearing the OK lens group,the average axial length increased by 0.15±0.21(mm),and the second year was 0.14±0.20(mm).There was no significant difference between the two years(P>0.05).The average eye axis of the frame glasses group increased by 0.33±0.16(mm)in the first year and 0.34±0.15(mm)in the second year.The difference was not statistically significant(P>0.05).The OK lens group and the frame glasses group 2 In the comparative study,the difference was statistically significant(P<0.05).Conclusions:Compared with the frame glasses,the Orth-K lens can effectively control the development of myopia in adolescents.Wearing an Orth-K lens can slow the growth of the eye axis.The annual growth of the eye axis can slow down by more than 50%.Wearing OK lens can reduce the increase rate of myopia and slow down the increase rate of myopic degrees by more than 60%. |
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