ChiCTR2500100642 版本V1.0 版本创建时间2025/04/11 17:06:45 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500100642 

最近更新日期：

Date of Last Refreshed on：

2025-04-11 17:06:36 

注册时间：

Date of Registration：

2025-04-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

不同基弧区设计角膜塑形镜对近视青少年儿童视觉质量影响的前瞻性临床研究

Public title：

A Prospective Clinical Investigation of the Impact of Orthokeratology Lenses with Varied Curve Zone on Visual Quality in Pediatric Myopia Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同大小基弧区设计的角膜塑形镜在近视矫治中的光学质量及对比敏感度视力分析

Scientific title：

Analysis of Optical Quality and Contrast Sensitivity in Myopic Correction Using Orthokeratology Lenses with Varied Base Curve Zone Diameters

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘艳 

研究负责人：

刘艳 

Applicant：

Yan Liu 

Study leader：

Yan Liu 

申请注册联系人电话：

Applicant telephone：

+86 571 8662 5857

研究负责人电话：

Study leader's telephone：

+86 571 8662 5857

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

ly.holly@foxmail.com

研究负责人电子邮件：

Study leader's E-mail：

877613999@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省杭州市西湖区转塘街道之江家园5区19幢2单元2202

研究负责人通讯地址：

浙江省杭州市西湖区转塘街道之江家园5区19幢2单元2202

Applicant address：

2202, Unit 2, Building 19, Jiangjiayuan 5 District, Zhuantang Street, Xihu District, Hangzhou City,

Study leader's address：

2202, Unit 2, Building 19, Jiangjiayuan 5 District, Zhuantang Street, Xihu District, Hangzhou City,

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

杭州西湖之江眼科医院

Applicant's institution：

Hangzhou Xihu Zhijiang Eye Hospital

研究负责人所在单位：

杭州西湖之江眼科医院

Affiliation of the Leader：

Hangzhou Xihu Zhijiang Eye Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

杭州西湖之江眼科医院伦审2024研第2号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

杭州西湖之江眼科医院医学伦理委员会

Name of the ethic committee：

Hangzhou Xihu Zhijiang Eye Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-20 00:00:00

伦理委员会联系人：

曾华英

Contact Name of the ethic committee：

Ceng HuaYing

伦理委员会联系地址：

西湖区转塘街道象山366号

Contact Address of the ethic committee：

366 Xiangshan, Zhuantang Street, Xihu District

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 81109666

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2227886719@qq.com

研究实施负责（组长）单位：

杭州西湖之江眼科医院

Primary sponsor：

Hangzhou Xihu Zhijiang Eye Hospital

研究实施负责（组长）单位地址：

西湖区转塘街道象山366号

Primary sponsor's address：

366 Xiangshan, Zhuantang Street, Xihu District

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

杭州西湖之江眼科医院

具体地址：

西湖区转塘街道象山366号

Institution
hospital：

Hangzhou Xihu Zhijiang Eye Hospital

Address：

366 Xiangshan, Zhuantang Street, Xihu District

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-funded

Target disease：

The specific diseases or symptoms encompassed in the research primarily pertain to myopia among adolescents and children. Myopia is a common refractive disorder of the eye, manifested as the focusing of parallel light rays in front of the retina when the eye is in a relaxed accommodative state, leading to indistinct vision of distant objects while near objects are relatively clear. In this study,

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探究不同大小基弧区设计的角膜塑形镜对近视青少年儿童矫治过程中的光学质量的影响。通过检测患者配戴不同基弧区角膜塑形镜后波前像差、视觉质量问卷调查等指标的变化，评估不同基弧设计的镜片在主观及客观视觉质量方面的差异，为角膜塑形镜的优化设计与临床精准应用提供科学依据。  

Objectives of Study：

This study aimed to investigate the impact of orthokeratology lenses with varying base arcs on the optical quality in myopia patients. By assessing changes in wavefront aberration and visual quality through questionnaires after patients wore lenses with different base arc designs, this research evaluated both subjective and objective visual quality differences. These findings provide a scientific foundation for optimizing lens design and ensuring accurate clinical application of orthokeratology lenses.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄8～13岁之间；
2.双眼近视度数为-1.00～-4.00 D，顺规散光且＜＝1.75 D；
3.初次验配角膜塑形镜。

Inclusion criteria

1.The age range is between 8 and 13 years old;
2.Myopia degree in both eyes ranged from -1.00D to -4.00D, with astigmatism less than 1.75D;
3.Initial fitting of orthokeratology lenses.

排除标准：

1.眼科手术史；影响视力和屈光度变化的眼科疾病，如白内障、 青光眼等； 2.影响视力和屈光度变化的全身系统性疾病，如糖尿病等； 3.依从性差，不能按时随访或配合检查者。 4.3月内使用低浓度阿托品或其他影响瞳孔大小的药物；

Exclusion criteria：

1.The use of low-concentration atropine or other drugs affecting pupil size within three months; 2.A history of ophthalmic surgery; Ocular conditions impacting vision and refractive changes, such as cataracts or glaucoma; 3.Systemic diseases potentially affecting vision and refraction, such as diabetes mellitus; 4.Poor compliance, inability to adhere to scheduled follow-ups, or failure to cooperate during examinations.

研究实施时间：

Study execute time：

从 From 2025-04-16 00:00:00至 To 2028-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-16 00:00:00 至 To 2026-04-16 00:00:00  

干预措施：

Interventions：

组别：

基弧5.0mm

样本量：

39

Group：

BC5.0mm

Sample size：

干预措施：

5.0mm基弧区设计的角膜塑形镜

干预措施代码：

Intervention：

Orthokeratology with different base arc designs

Intervention code：

组别：

基弧6.0mm

样本量：

39

Group：

A 5.8mm orthokeratoscope with a base arc design

Sample size：

干预措施：

6.0mm基弧区设计的角膜塑形镜

干预措施代码：

Intervention：

A 6.0mm orthokeratoscope with a base arc design

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

杭州西湖之江眼科医院 

单位级别：

无 N/A 

Institution
hospital：

Hangzhou Xihu Zhijiang Eye Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

主观视觉质量问卷调查评分

指标类型：

主要指标

Outcome：

Subjective Visual Quality Assessment Score

Type：

Primary indicator

测量时间点：

配戴ok镜后第1天、第1周、第1个月、第3个月、第6个月和第12个月

测量方法：

采用专门设计的视觉质量问卷，涵盖视力清晰度、眩光、重影、夜间视力等方面，采用Likert量表评分，由受试者根据自身感受填写

Measure time point of outcome：

On day 1, week 1, month 1, month 3, month 6, and month 12 following the initiation of OK lens wear

Measure method：

A specifically designed visual quality questionnaire, encompassing aspects such as vision clarity, glare, diplopia, and night vision, was utilized. The questionnaire employed a Likert scale for scoring and was completed by participants based on their personal experiences.

指标中文名：

全眼高阶像差（HOA）、球差（SA）、彗差、三叶草差

指标类型：

主要指标

Outcome：

Whole-eye higher-order aberrations (HOA), including spherical aberrations (SA), coma, and trefoil aberrations

Type：

Primary indicator

测量时间点：

在配戴OK镜之前以及配戴后的第1天、第1周、第1个月、第3个月、第6个月和第12个月

测量方法：

采用波前像差仪对OPD-SCAN III进行测量，并在测量前对仪器进行校准。指示患者以舒适的姿势坐着，注视器械内指定的目标。获得至少三个有效数据集，然后取平均值进行分析。

Measure time point of outcome：

Prior to wearing the OK lens and on day 1, week 1, month 1, month 3, month 6, and month 12 post-init

Measure method：

A wavefront aberrator was employed to measure the OPD-SCAN III, and the instrument was calibrated before the measurement process. The patient was instructed to sit in a comfortable position and fixate on a designated target within the instrument. At least three valid data sets were acquired and subsequently averaged for analysis.

指标中文名：

眼轴长度控制效果及角膜地形图形态

指标类型：

次要指标

Outcome：

The Influence of Axial Length and Corneal Topographic Shape on Control Effectiveness

Type：

Secondary indicator

测量时间点：

配戴ok镜后第1天、第1周、第1个月、第3个月、第6个月和第12个月

测量方法：

分辨率角膜地形图仪（品牌：medmont 角膜地形图仪 E300USB） 眼轴长度测量仪（品牌：ZEISS蔡司 眼科光学生物测量仪 IOL Master 700）

Measure time point of outcome：

Prior to wearing the OK lens and on day 1, week 1, month 1, month 3, month 6, and month 12 post-init

Measure method：

The corneal topographic analysis was conducted using the Medmont E300USB Corneal Topographer. The axial length measurements were obtained with the ZEISS IOLMaster 700, an advanced ophthalmic optical biometer.

指标中文名：

眼部疼痛、眼红、视力下降、角膜上皮损伤等事件

指标类型：

次要指标

Outcome：

Occurrences of eye pain, redness, vision impairment, and corneal epithelial injury were documented

Type：

Secondary indicator

测量时间点：

配戴ok镜后第1天、第1周、第1个月、第3个月、第6个月和第12个月

测量方法：

临床观察、裂隙灯检查、标准视力表检查、荧光素染色检查

Measure time point of outcome：

On day 1, week 1, month 1, month 3, month 6, and month 12 following the initiation of OK lens wear

Measure method：

Clinical observation, slit-lamp examination, standard visual acuity testing, and fluorescein staining evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 8 岁 years
最大 Max age 13 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由统计学专家廉恒丽用随机化在SPSS中通过语法编程实现，步骤如下：1. 将样本分成多个区组。 2. 在每个区组内随机分配到3组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Statistics expert Yeom Hengli utilized SPSS software, the randomization method, and grammatical programming to achieve sample allocation. The specific procedures are as follows:1. The sample was stratified into several blocks. 2. Within each block, the samples were randomly assigned to three experimental groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲

Blinding：

Single blind study

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本研究产生的数据包含大量近视青少年儿童的敏感信息，尽管在研究过程中采取了严格的数据保护措施，但考虑到数据隐私的极端重要性，决定不对研究数据进行共享。本研究团队在数据收集、整理及分析过程中投入了大量的时间和精力，研究成果尚处于持续深入挖掘与完善阶段。为保障研究成果的完整性和知识产权，防止数据被不当使用或恶意篡改，经审慎评估，决定暂不对外共享数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The data generated by this study encompasses a substantial amount of sensitive information pertaining to myopic adolescents and children. Despite the implementation of stringent data protection measures throughout the study, it has been determined that sharing the study data is inadvisable due to the paramount importance of safeguarding data privacy. the research team has invested considerable time and effort into the collection, organization, and analysis of the data, with the research findings currently undergoing continuous refinement and enhancement. To protect the integrity and intellectual property rights of the research outcomes and prevent any improper use or malicious tampering of the data, it has been carefully evaluated and decided not to publicly share the data at this juncture.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

一、数据采集 采集内容：涵盖受试者基本信息，包括姓名、年龄、近视度数等，用于关联个体特征与研究结果。视觉质量数据、对比敏感度、高阶像差，并记录主观感受。安全性指标聚焦眼部疼痛、眼红、视力下降、角膜上皮损伤等情况。 采集方法：视觉质量数据等客观指标由专业人员，多次取均值。通过简洁问卷收集佩戴舒适度等主观感受，眼科医生借助裂隙灯显微镜按标准观察眼部体征。 采集频率：受试者入组时完成基线采集，配戴角膜塑形镜后，第1周、1 个月、3 个月、6 个月及12个月随访采集，以便及时发现问题。 二、数据管理 数据存储：运用 MySQL 构建结构化数据库，依数据类型设表，用受试者编号关联各表。经培训的数据录入员采用双人双录入确保准确。 数据备份：每周全量备份数据库，每月异地备份，存于专用设备，定期检查，记录备份详情。 数据安全：依职责设访问权限，如数据分析员仅能访问脱敏数据。敏感数据用 SSL/TLS 加密，建立审计机制审查访问记录，加强人员安全培训。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1.Data Collection Content: The basic information of subjects, including name, age, myopia degree, etc., was collected to correlate individual characteristics with research outcomes. Visual quality data, contrast sensitivity, high-order aberrations, and subjective perceptions were recorded. Safety indicators focused on eye pain, redness, vision loss, corneal epithelial damage, and other conditions. Acquisition Method: Objective indicators such as visual quality data were averaged by professionals. Subjective feelings like wearing comfort were collected through structured questionnaires, and ophthalmologists observed ocular signs using slit-lamp microscopy according to standardized protocols. Collection Frequency: Baseline data were collected upon subject enrollment, and follow-up data were gathered at 1 week, 1month, 3months, 6months, and 12 months post-orthokeratology lens wear to promptly identify any issues. 2.Data Management Data Storage: A structured database was built using MySQL, with tables created based on data types and linked to subject identification numbers. Trained data entry clerks used double-entry verification to ensure accuracy. Data Backup: Full backups were performed weekly, and remote backups were conducted monthly, stored in dedicated equipment with regular checks and detailed backup logs. Data Security: Access was role-based, with data analysts having access only to desensitized data. Sensitive data were encrypted using SSL/TLS, an audit mechanism was established to review access records, and personnel received ongoing security training.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-04-11 17:06:36