Song Yilin, Chen Jiayan, Qin Guanghao, Xu Ling, He Wei, Yu Sile, Pazo Emmanuel Eric, He Xingru
He Eye Specialist Hospital, Shenyang, China.
Dalian Medical University, Dalian, China.
Heliyon. 2024 Sep 12;10(18):e37779. doi: 10.1016/j.heliyon.2024.e37779. eCollection 2024 Sep 30.
The prevalence of myopia among adolescents is increasing precipitously in China, and the popularity of orthokeratology (OK) lenses as an effective treatment for controlling myopia progression is rising. This protocol assessed and compared the clinical dry eye parameters in children and adolescents with myopia treated with spectacles or OK lenses.
This single-masked randomized control trial will include 300 participants (aged 8-17 years) with myopia treated with OK lens (study group) or spectacles (control group). We will record the ocular surface disease index, visual analog scale score, noninvasive tear breakup time, tear meniscus height, meibomian gland score, ocular redness score, visual acuity, tear Matrix Metalloproteinase-9 concentration, tear Lymphotoxin alpha levels at baseline, and after 1-, 3-, 6-, and 12-month.
This study will be a standardized, scientific, clinical trial designed to evaluate the dry eye parameters in children and adolescents with myopia treated with OK lenses for myopia control.
This study has been approved by the Ethics Committee of He Eye Specialist Hospital [ethics approval number: IRB(2023)K024.01]. Before participating in the trial, written informed consent will be obtained from all patient's parents or guardians. The findings of this study will be showcased at both local and international conferences and will also be submitted for publication in reputable peer-reviewed journals.
Clinicaltrials.gov: NCT06023108 {2a, 2b}.
在中国，青少年近视患病率急剧上升，角膜塑形术（OK）镜片作为控制近视进展的有效治疗方法越来越受欢迎。本方案评估并比较了佩戴眼镜或OK镜片治疗的近视儿童和青少年的临床干眼参数。
这项单盲随机对照试验将纳入300名8至17岁的近视参与者，他们分别接受OK镜片治疗（研究组）或眼镜治疗（对照组）。我们将记录眼表疾病指数、视觉模拟量表评分、非侵入性泪膜破裂时间、泪河高度、睑板腺评分、眼红评分、视力、泪液基质金属蛋白酶-9浓度、泪液淋巴毒素α水平，记录时间点为基线时以及1个月、3个月、6个月和12个月后。
本研究将是一项标准化、科学性的临床试验，旨在评估使用OK镜片控制近视的儿童和青少年的干眼参数。
本研究已获得何氏眼科专科医院伦理委员会的批准[伦理批准号：IRB(2023)K024.01]。在参与试验前，将从所有患者的父母或监护人处获得书面知情同意书。本研究的结果将在国内和国际会议上展示，并将提交至知名同行评审期刊发表。
Clinicaltrials.gov：NCT06023108 {2a, 2b}
