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陈晓航, 熊燕, 王将栏, 等. 中低度近视儿童/青少年长期配戴角膜塑形镜后角膜安全性的前瞻性研究[J]. 四川大学学报(医学版), 2021, 52(6): 1006-1010. DOI: 10.12182/20211160107
引用本文: 陈晓航, 熊燕, 王将栏, 等. 中低度近视儿童/青少年长期配戴角膜塑形镜后角膜安全性的前瞻性研究[J]. 四川大学学报(医学版), 2021, 52(6): 1006-1010. DOI: 10.12182/20211160107
CHEN Xiao-hang, XIONG Yan, WANG Jiang-lan, et al. Prospective Study on Corneal Safety Evaluation of Children/Adolescents with Low and Moderate Myopia after Long-Term Orthokeratology[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(6): 1006-1010. DOI: 10.12182/20211160107
Citation: CHEN Xiao-hang, XIONG Yan, WANG Jiang-lan, et al. Prospective Study on Corneal Safety Evaluation of Children/Adolescents with Low and Moderate Myopia after Long-Term Orthokeratology[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(6): 1006-1010. DOI: 10.12182/20211160107

中低度近视儿童/青少年长期配戴角膜塑形镜后角膜安全性的前瞻性研究

Prospective Study on Corneal Safety Evaluation of Children/Adolescents with Low and Moderate Myopia after Long-Term Orthokeratology

  • 摘要:
      目的   观察中低度近视儿童/青少年在长期配戴角膜塑形镜后,其角膜完整性、角膜内皮细胞可能出现的变化及相关变化的节点,探讨长期配戴角膜塑形镜的安全性,为受试者配戴角膜塑形镜的安全评估提供参考。
      方法   开展为期3年的前瞻性研究,在四川大学华西医院隐形眼镜门诊招募并纳入受试者。分别于受试者戴镜前,戴镜后1个月、3个月、6个月检测一次,之后每三个月测量一次数据直至36个月,检测中央区角膜厚度(CCT)、角膜内皮细胞密度(ECD)、六角形细胞比(HEX)等的变化,记录戴镜者每次随访时角膜荧光染色结果,若观察到角膜染色,采用Efron分级标准进行分级并做相应处理。
      结果   本研究共纳入33例(66眼)受试者,戴镜1周内受试者戴镜后报告双眼异物感、流泪15例(46.2%),适应后症状消失,未进行干预。随访期内共出现双眼角膜染色31例(93.94%),其中24例(72.73%)角膜染色为G0级,5例(15.15%)为GⅠ,2例(6.06%)为GⅡ级,对GⅠ和GⅡ角膜染色进行相应临床处理。本研究中受试者的角膜内皮细胞密度与年龄呈反比(r=−0.380, P=0.002),随访期间,受试者左眼ECD从戴镜第24个月开始、右眼ECD从戴镜第27个月开始较基线值下降(P<0.05),CCT结果显示CCT在戴镜后1个月变薄(P<0.05),后续CCT呈现稳定趋势。
      结论   经过3年长期随访,中低度近视儿童/青少年在长期配戴角膜塑形镜后未发生任何严重角膜并发症,戴镜24个月以后双眼ECD开始下降,戴镜1个月后CCT降低。

     

    Abstract:
      Objective   To observe the possible changes in the integrity of the cornea and corneal endothelial cells of children/adolescents with low or moderate myopia after long-term wearing of orthokeratology (ortho-k) lenses, as well as the time when the relevant changes occur, so as to evaluate the safety of long-term wearing of ortho-k lens and to provide a reference for the safety evaluation of subjects wearing ortho-k lenses.
      Methods   Subjects were recruited in the Contact Lens Clinic, West China Hospital, Sichuan University for a three-year prospective study. Ortho-k of the same brand was matched for the subjects. The central corneal thickness (CCT), corneal endothelial cell density (ECD), and hexagonal cell ratio (HEX) were measured prior to the wearing of ortho-k lenses and after wearing ortho-k lenses for 1 month, 3 months, 6 months, and every 3 months until 36 months. The results of corneal fluorescence staining were recorded during each follow-up. When corneal staining was observed, the Efron grading standard was used for grading and corresponding treatment was given.
      Results   A total of 33 (66 eyes) myopic patients were included in the study. 15 cases (46.2%) reported having binocular foreign body sensations and tearing within the first week of wearing the lenses. After the subjects became adapted to wearing the lenses, the symptoms disappeared without intervention. During the follow-up period, 31 cases (93.94%) of binocular corneal staining were observed, of which, 24 cases (72.73%) were graded as G0, receiving no treatment, 5 cases (15.15%) were graded as GⅠ, and 2 cases (6.06%) were graded as GⅡ. Corresponding clinical treatment for corneal staining was given to the GⅠ and GⅡ subjects. This study found that the corneal ECD was inversely proportional to age (r=-0.380, P=0.002). During the three-year follow-up period, the subjects’ left eye ECD decreased from the baseline at 24 months and the right eye ECD decreased from the baseline at 27 months (P<0.05). The CCT results in the subjects showed that CCT became thinner at 1 month after wearing the lens (P<0.05), but the follow-up CCT showed a stable trend.
      Conclusion   After three years of long-term follow-up, no serious corneal complications occurred in children/adolescents with moderate and low myopia after long-term wearing of ortho-k lens. The corneal ECD of both eyes started decreasing 24 months after wearing the ortho-k lenses and the CCT decreased 1 month after wearing the lenses.

     

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