中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100049130
最近更新日期： Date of Last Refreshed on：	2021-07-21 05:25:21
注册时间： Date of Registration：	2021-07-21 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	采用双眼非同步视觉影像训练改善弱视
Public title：	Using Binocular Asynchronous Visual Images to Improve Amblyopic Eyes
注册题目简写：
English Acronym：
研究课题的正式科学名称：	采用双眼非同步的视觉影像训练与传统疗法改善屈光参差型弱视的随机对照研究
Scientific title：	A Randomized Controlled Study on lmproving Anisometropic Amblyopia with Binocular Asynchronous Visual lmages Training and Traditional Occlusion Therapy
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：	黄鑫	研究负责人：	濮鸣亮
Applicant：	Xin Huang	Study leader：	Mingliang Pu
申请注册联系人电话： Applicant telephone：	+86 18601064640	研究负责人电话： Study leader's telephone：	+86 13501177695
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：	chrox.huang@gmail.com	研究负责人电子邮件： Study leader's E-mail：	mpu@bjmu.edu.cn
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：	北京市海淀区学院路38号解剖楼315	研究负责人通讯地址：	北京市海淀区学院路38号解剖楼315
Applicant address：	Suite 315, Anatomy Building, 38 Xueyuan Road, Haidian District, Beijing, China	Study leader's address：	Suite 315, Anatomy Building, 38 Xueyuan Road, Haidian District, Beijing, China
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：	北京大学基础医学院
Applicant's institution：	Peking University School of Basic Medical Sciences
研究负责人所在单位：	北京大学基础医学院
Affiliation of the Leader：	Peking University School of Basic Medical Sciences

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	IRB00001052-13037	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：	北京大学生物医学伦理委员会
Name of the ethic committee：	Peking University Institutional Review Board
伦理委员会批准日期： Date of approved by ethic committee：	2014-04-24 00:00:00
伦理委员会联系人：	赵励彦
Contact Name of the ethic committee：	Liyan Zhao
伦理委员会联系地址：	北京市海淀区学院路38号北京大学医学部逸夫教学楼501室
Contact Address of the ethic committee：	Suite 501, Yifu Teaching Building, 38 Xueyuan Road, Haidian District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 010-82805751	伦理委员会联系人邮箱： Contact email of the ethic committee：	llwyh@bjmu.edu.cn

研究实施负责（组长）单位：

北京大学基础医学院

Primary sponsor：

Peking University School of Basic Medical Sciences

研究实施负责（组长）单位地址：

北京市海淀区学院路38号

Primary sponsor's address：

38 Xueyuan Road, Haidian District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京市	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学第一医院	具体地址：	北京市西城区西什库大街8号
Institution hospital：	Peking University First Hospital	Address：	8 Xishiku Street, Xicheng District, Beijing

经费或物资来源：

科技部和国家自然科学基金委

Source(s) of funding：

Ministry of Science and Technology of the People's Republic of China & National Natural Science Foundation of China

研究疾病：

弱视

Target disease：

Amblyopia

研究疾病代码：

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：

本研究的主要目的是比较双眼异步接受图像刺激的视觉训练方法与传统遮挡法治疗对弱视患者改善眼优势的作用，并评估接受双眼间隔8ms的视觉图像训练对改善和治疗儿童屈光参差性弱视的有效性。

Objectives of Study：

The main purpose of this study is to compare the visual training method of asynchronously receiving image stimulation in both eyes and the traditional occlusion method in improving the ocular dominance of patients with amblyopia, and to evaluate the effectiveness of improvement and treatment of children with anisometropic amblyopia by receiving visual image training with an interval of 8 ms between the eyes.

药物成份或治疗方案详述：

本项研究拟在4 -8岁儿童屈光参差性弱视患者中展开。性别比例为1：1。临床检查未发现双眼的器质性病变，且非优势眼的矫正远视力在0.2到0.6之间，优势眼矫正视力大于0.5的患者可入选研究目标人群。计划招募50-60名受试者。受试者按照1：1划分为实验组和对照组，实验组受试者接受连续 5周每天 45 分钟的非同步的视觉影像训练；对照组采用每天至少6小时的遮挡优势眼的治疗。训练结束后我们需要每个月对仅接受了规定视觉训练的受试者进行视力复检一次，共复检6次。如果在训练过程中患儿还接受其他训练，他/她将不被包括在后续复查中。训练过程中每周测量一次双眼矫正视力，其中矫正视力采用国际标准视力表检测远视力。根据获得的实验数据的结构和类型采用包括T-test 及ANOVA在内的等不同统计学手段进行数据分析。

Description for medicine or protocol of treatment in detail：

This study is planned to be carried out in children with anisometropic amblyopia from 4 to 8 years old. The sex ratio is 1:1. Clinical examination did not find any organic disease in both eyes, and the corrected distance visual acuity of the non-dominant eye was between 0.2 and 0.6, and patients whose corrected visual acuity of the dominant eye was greater than 0.5 could be selected as the target population for the study. It is planned to recruit 50-60 subjects. The subjects were divided into the experimental group and the control group according to 1:1. The subjects in the experimental group received 45 minutes of non-synchronized visual imaging training every day for 5 weeks; the control group received at least 6 hours of treatment to cover the dominant eye every day. After the training, we need to re-examine the eyesight of subjects who have only received the prescribed vision training once a month, for a total of 6 re-examinations. If the child receives other training during the training, he/she will not be included in the follow-up review. During the training, the corrected visual acuity of both eyes was measured once a week, and the corrected visual acuity was measured by the international standard visual acuity chart. According to the structure and type of the experimental data obtained, different statistical methods including T-test and ANOVA are used for data analysis.

纳入标准：

Inclusion criteria

1. Children 4-8 years old with no obvious ocular pathology, including optic nerve or macular lesions, media opacities, or abnormalities of the central visual pathways;
2. Significant anisometropia (>1.5 D difference between eyes in spherical equivalent; >1.0 D difference between the eyes in astigmatism, in any meridian.);
3. Optimal refraction prescribed by clinicians with extensive expertise in amblyopia. All had been wearing glasses for more than 3 months and had stable best-corrected visual acuity before entering the study;
4. VA in the AE before treatment between 20/32 Snellen acuity (0.2 logMAR) and 20/200 (1.0 logMAR). This definition for the threshold for amblyopia is slightly more stringent than that of the American Academy of Ophthalmology (VA in the AE before treatment 20/30 Snellen, 0.18 logMAR, or worse) 69. The majority of children had initial VA in the AE worse than 0.3 logMAR;
5. The physical examination of Peking University First Hospital confirmed that the participants had normal psychophysiological development and did not suffer from any acute or chronic diseases or genetic visual system diseases.

排除标准：

[1] 不符合弱视眼程度甄别条件。
[2] 临床检查发现双眼有器质性病变。
[3] 实验组的参与者之前接受过任何纠正弱视的视觉训练。对照组的参与者仅接受过多于四周的单纯遮挡训练。
[4] 经北京大学第一医院体检证实参与者心理生理发育不正常或患有任何急慢性疾病或遗传型视觉系统疾病。
[5] 自愿受试者被发现具有上述任一项检查结果时排除参与本项研究。

Exclusion criteria：

1. Does not meet the screening criteria for the degree of amblyopia;
2. Clinical examination revealed any ocular disease in both eyes;
3. Participants in the experimental group had previously received any visual training to correct amblyopia. Participants in the control group received more than four weeks of occlusion treatment;
4. The physical examination of Peking University First Hospital confirmed that the participants had abnormal psychophysiological development or had any acute or chronic diseases or genetic visual system diseases;
5. Voluntary subjects are excluded from participating in this study when they are found to have any of the above-mentioned examination results;
6. Children assigned to a movie-viewing group received any other form of visual training therapy during the study period.

研究实施时间：

Study execute time：

从 From 2014-07-01 00:00:00至 To 2015-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2014-05-01 00:00:00 至 To 2014-07-01 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	22
Group：	Experiment	Sample size：	22
干预措施：	视觉训练	干预措施代码：
Intervention：	Visual Training	Intervention code：

组别：	对照组	样本量：	22
Group：	Control	Sample size：	22
干预措施：	遮盖法	干预措施代码：
Intervention：	Patching	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京市	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学第一医院	单位级别：	三级甲等医院
Institution hospital：	Peking University First Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	视敏度值	指标类型：	主要指标
Outcome：	Distance Visual Acuity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	4	岁 years
最大 Max age	8	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）：

当受试者符合纳入标准时，将会被分配到一个唯一的受试者序号。受试者具有相同的机会被分配到实验组和对照组（分配采用抽签的方式或者计算机根据受试者序号随机生成）。

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

When subjects meet the inclusion criteria, they will be assigned a unique subject number. Subjects had the equal chance to be assigned to the experimental group or the control group. The allocation was determined by subject's serial number, which was randomly generated by computer program.

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：	N/A
Blinding：	N/A

是否共享原始数据： IPD sharing	是Yes
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）：	临床试验公共管理平台ResMan（www.medresman.org）
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Public management platform for clinical trials ResMan（www.medresman.org）
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：	研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表。当所有病例报告表经核对无误后，由数据管理员写出数据检查报告，其内容包括研究完成情况（含脱落受试者清单）、入选/排除标准检查、完整性检查、逻辑一致性检查、离群数据检查、时间窗检查、不良事件检查等。病例报告表在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按相应规定内的期限保存。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	According to the original observation records of the subjects, the researcher loaded the data into the case report form in a timely, complete, correct and clear manner. When all the case report forms are verified, the data manager will write a data inspection report, which includes the completion of the study (including the list of dropped subjects), selection/exclusion criteria check, completeness check, logical consistency check, Outlier data check, time window check, adverse event check, etc. After completing data entry and verification as required, the case report form is archived and stored in the order of numbers, and filled with a search catalog for future reference. Electronic data files include databases, inspection procedures, analysis procedures, analysis results, codebooks and explanatory documents, etc., which should be stored in categories, and multiple backups should be stored on different disks or recording media, and be properly stored to prevent damage. All original archives shall be kept within the time limit within the corresponding regulations.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2021-07-21 05:22:32