ChiCTR2300079099 版本V1.0 版本创建时间2023/12/25 17:42:17 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：

ChiCTR2300079099 

最近更新日期：

Date of Last Refreshed on：

2023-12-25 17:41:49 

注册时间：

Date of Registration：

2023-12-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

远红外功能眼镜治疗干眼的有效性

Public title：

Clinical trial study on the effectiveness of far-infrared functional glasses in the treatment of dry eye

注册题目简写：

English Acronym：

研究课题的正式科学名称：

远红外功能眼镜治疗干眼的有效性临床试验研究

Scientific title：

Clinical trial study on the effectiveness of far-infrared functional glasses in the treatment of dry eye

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：

郭一涵 

研究负责人：

田磊 

Applicant：

Guo Yihan 

Study leader：

Tian Lei 

申请注册联系人电话：

Applicant telephone：

+86 188 1163 8606

研究负责人电话：

Study leader's telephone：

+86 135 1102 6669

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：

guoyihan2000@163.com

研究负责人电子邮件：

Study leader's E-mail：

tianlei0131@163.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：

北京市东城区东交民巷1号

研究负责人通讯地址：

北京市东城区东交民巷1号

Applicant address：

1 Dong Jiao Min Xiang, Dong Cheng District, Beijing 100730, China

Study leader's address：

1 Dong Jiao Min Xiang, Dong Cheng District, Beijing 100730, China

申请注册联系人邮政编码：

Applicant postcode：

18600166885

研究负责人邮政编码：

Study leader's postcode：

18600166885

申请人所在单位：

首都医科大学附属北京同仁医院

Applicant's institution：

Beijing Tongren Hospital

研究负责人所在单位：

首都医科大学附属北京同仁医院

Affiliation of the Leader：

Beijing Tongren 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：

TREC2022-KY005

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：

首都医科大学附属北京同仁医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Tongren Hospital, Affiliated with Capital Medical University.

伦理委员会批准日期：

Date of approved by ethic committee：

2022-03-31 00:00:00

伦理委员会联系人：

武峰

Contact Name of the ethic committee：

Wu Feng

伦理委员会联系地址：

北京市东城区东交民巷1号

Contact Address of the ethic committee：

1 Dong Jiao Min Xiang, Dong Cheng District, Beijing 100730, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5826 8422

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京同仁医院

Primary sponsor：

Beijing Tongren Hospital

研究实施负责（组长）单位地址：

北京市东城区东交民巷1号

Primary sponsor's address：

1 Dong Jiao Min Xiang, Dong Cheng District, Beijing 100730, 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(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

Beijing

具体地址：

北京市东城区东交民巷1号

Institution
hospital：

Beijing Tongren Hospital

Address：

1 Dong Jiao Min Xiang, Dong Cheng District, Beijing 100730, China

经费或物资来源：

意得凯（深圳）科技有限责任公司

Source(s) of funding：

Edekai (Shenzhen) Technology Co., LTD

Target disease：

dry eye

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价远红外功能眼镜治疗干眼的有效性。  

Objectives of Study：

To evaluate the effectiveness of far-infrared functional glasses in the treatment of dry eyes.

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）自愿参加本项临床研究，并签署知情同意书。 （2）性别不限，年龄18～70周岁。 （3）有干眼的临床症状和体征，临床检查可诊断为睑板腺功能障碍相关干眼： 当患者同时满足干眼和睑板腺功能障碍的诊断标准时，被诊断为睑板腺功能障碍相关干眼 干眼是根据TFO Dews II (2017版)诊断的：(1)症状：眼表疾病指数（OSDI）问卷≥13分或干眼严重程度评分(VAS)≥6分；(2)下列稳态标志物至少一项阳性结果：荧光素泪膜破裂时间≤10s，双眼或眼间泪液渗透压差>8mOsm/L，眼表面染色：角膜着色点>5个，结膜着色点>9个，或眼睑边缘着色[≥2 mm长度&≥25%宽度]。 根据MGD国际研讨会，睑板腺功能障碍可诊断为：(1)临床体征：睑板腺脱落、睑板腺分泌物改变和形态改变；(2)全身不适症状，如红肿、瘙痒、刺激、酸痛。（4）角膜荧光素无染色或点状着色，着色点可数（且染色数≤30点）及结膜荧光素染色0-Ⅲ级； （4）角膜荧光素无染色或点状着色可数（且染色数≤30点）及结膜荧光素染色0-Ⅲ级； （5）试验2星期内未参加过其它临床试验。 （6）未正在使用其他治疗干眼，或正在使用其他治疗但已停止2周以上。

Inclusion criteria

(1) Voluntarily participate in this clinical study and sign informed consent. (2) Gender is not limited, age 18-70 years old. (3) There are clinical symptoms and signs of dry eye, clinical examination can be diagnosed as meibomian gland dysfunction related dry eye: When patients meet the diagnostic criteria for both dry eye and meibomian gland dysfunction, they are diagnosed with meibomian gland dysfunction associated dry eye Dry eye was diagnosed according to TFO Dews II (2017 edition) : (1) Symptoms: Ocular Surface Disease Index (OSDI) questionnaire ≥13 points or dry eye Severity scale (VAS)≥6 points; (2) At least one positive result of the following steady state markers: fluorescein tear film rupture time ≤10s, tear osmotic pressure difference between eyes or eyes > 8mOsm/L, eye surface staining: corneal staining points > 5, conjunctiva staining spots > 9, or colored eyelid edges [≥2 mm length &≥25% width]. According to the MGD International Symposium, meibomian gland dysfunction can be diagnosed as: (1) Clinical signs: meibomian gland detachment, meibomian gland secretion changes and morphological changes; (2) General discomfort symptoms, such as redness, swelling, itching, irritation, and soreness. (4) Corneal fluorescein does not stain or spot coloring, the coloring points are countable (and the staining number is less than 30 points) and conjunctival fluorescein staining 0-Ⅲ grade; (4) corneal fluorescein without staining or dot staining countable (and the number of staining ≤30 points) and conjunctival fluorescein staining 0-Ⅲ grade; (5) Did not participate in other clinical trials within 2 weeks of the trial. (6) are not using other treatments for dry eye, or are using other treatments but have stopped for more than 2 weeks.

排除标准：

凡有下列情况之一者，不作为入选病例： （1）孕妇或哺乳期女性或近期有生育计划者。 （2）患有其他眼科疾病者。 （3）泪膜破裂时间＝0秒，或泪液分泌实验=0毫米/5分钟者。 （4）全角膜染色点数大于30点、有片状着色融合或出现丝状物。 （5）重度MGD患者（4级）。 （6）合并有严重心、脑血管、肝、肾及造血系统等严重原发病。 （7）近六个月内有内眼手术或眼部外伤者。 （8）试验期间无法停戴角膜接触镜者。 （9）全身或眼部长期用药可能影响研究评估患者。 （10）在试验期间无法保证按要求使用设备及随访者。 （11）Sjogren’s综合症、系统性疾病以及影响疗效评价的其他眼部疾病。 （12）研究者认为有任何不适合参加试验理由者。

Exclusion criteria：

Any one of the following circumstances is not considered as an enrolled case: (1) Pregnant or lactating women or those who have a family plan recently. (2) Patients with other eye diseases. (3) Tear film rupture time =0 seconds, or tear secretion experiment =0 mm /5 minutes. (4) Total corneal staining is greater than 30 points, there are flaky coloring fusion or filamentous objects. (5) Patients with severe MGD (grade 4). (6) Complicated with serious primary disease of heart, cerebrovascular, liver, kidney and hematopoietic system. (7) Internal eye surgery or external eye injuries within the last six months. (8) Patients who could not stop wearing contact lenses during the test. (9) Long-term systemic or ocular medication may affect patients evaluated in the study. (10) The required use of equipment and visitors cannot be guaranteed during the test. (11) Sjogren's syndrome, systemic diseases, and other eye diseases that affect the evaluation of efficacy. (12) Those who have any reasons that the researcher deems unsuitable for participating in the experiment.

研究实施时间：

Study execute time：

从 From 2022-04-20 00:00:00至 To 2023-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-04-25 00:00:00 至 To 2023-12-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

70

Group：

experimental group

Sample size：

干预措施：

全天配戴远红外功能眼镜（清醒时配戴，睡觉时摘下）

干预措施代码：

Intervention：

Wear far-infrared functional glasses throughout the day (wear when awake, take them off when sleeping)

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(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京同仁医院 

单位级别：

三级，三甲 

Institution
hospital：

Beijing Tongren Hospital

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

角膜荧光素染色评分

指标类型：

附加指标

Outcome：

Corneal fluorescein staining score

Type：

Additional indicator

测量时间点：

第0,14,28天

测量方法：

检查者将向每只眼睛的下眼结膜囊滴注 5μL 2%不含防腐剂的荧光素钠溶液。为了使荧光素充分分布，检查者应在滴注后等待约2-3分钟，然后评估荧光素染色。

Measure time point of outcome：

Day 0, 14, and 28

Measure method：

The examiner will instill 5μL of 2% fluorescein sodium solution without preservatives into the lower conjunctival sac of each eye. To ensure adequate distribution of fluorescein, the examiner should wait for approximately 2-3 minutes after instillation, and then evaluate the fluorescein staining.

指标中文名：

眼干的严重程度评分

指标类型：

主要指标

Outcome：

visual analogue scale

Type：

Primary indicator

测量时间点：

第0,14,28天

测量方法：

要求受试者在水平线上画一垂直标记来表示他们自觉眼干的严重程度（0%表示“无干燥”和100%表示“最严重干燥”）。量表的线条长度应为100 mm（10 cm）

Measure time point of outcome：

Day 0, 14, and 28

Measure method：

Subjects are required to draw a vertical mark on a horizontal line to indicate the severity of their perceived eye dryness (0% representing "no dryness" and 100% representing "most severe dryness"). The length of the scale line should be 100 mm (10 cm). User :5 μL 2%.,. 30 , TFBUT. ,,.TFBUT,,.Wratten#12 TFBUT . ,.

指标中文名：

泪膜破裂时间

指标类型：

主要指标

Outcome：

breakup time of tear film

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Schirmer试验

指标类型：

次要指标

Outcome：

Schirmer test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

眼表疾病指数评分（OSDI评分）

指标类型：

主要指标

Outcome：

OSDI scores

Type：

Primary indicator

测量时间点：

第0,14,28天

测量方法：

Measure time point of outcome：

Day 0, 14, and 28

Measure method：

指标中文名：

睑板腺评估（MGD评分）

指标类型：

次要指标

Outcome：

Evaluation of meibomian glands

Type：

Secondary 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：

标本中文名：

无

组织：

Sample Name：

no

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

无

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

none

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：

Blinding：

是否共享原始数据：

IPD sharing

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）：

共享时间：试验完成后公开原始数据 (不超过试验结束后 6个月)。共享内容：原始数据表格及研究计划书。共享方式：可向研究者联系获取 研究者联系邮箱：tianlei0131@163.com

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

Share Time: The original data will be made publicly available after the completion of the experiment (within 6 months of the experiment's conclusion). Shared Content: The original data tables and the research protocol. Sharing Method: Researchers can obtain them by contacting the following email address of the researcher: tianlei0131@163.com.

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：

数据管理方法 1.数据记录 本研究将采用电子病例报告表（eCRF）进行研究数据的采集与管理。 研究者必须保留所有的研究记录和原始文件，保留的时间应该尽量长，应为相关法规和指南或研究单位规程所要求的最长时间，或者是申办方所规定的时间，以最长者为准。在销毁与研究有关的任何记录之前，研究者都必须先联合申办方。 如果研究者退出了研究（如职位变化、退休等），则记录应移交给相关都认可的指定人员（如另外一位研究者）。对于这样的移交，必须书面通知申办方。 1.1eCRF的填写 使用EDC采集临床研究数据。 可在eCRF上电子签名的每一个人都必须满足申办方的培训要求，而且只能使用申办方提供的，其本人专用的用户账号登陆电子数据采集系统。用户账号不得与他人共用，也不得再指定给其他人员。 填写：eCRF中的数据来自于原始病历和实验室检查报告单等原始文件并应与原始文件一致。试验中的任何观察、检查结果均应及时、正确、完整、清晰、规范、真实地填写于eCRF中，不得随意更改。CRF中的所有项目均需填写，不得空项或漏项。 修改：如有需要，eCRF作数据更正时，需按照系统提示，填写数据修改的原因。系统逻辑核查程序将对录入到EDC系统中的数据进行临床试验数据的完整性和逻辑性检查，并对问题数据产生错误信息提示，允许研究者或数据录入人员（CRC）对问题数据进行修改或解释，必要时可以多次发出质疑直至问题数据解决。 实验室检查：研究者应依据随访时间窗进行各项检查，采集、录入和报告受试者信息和数据，而且实验室检查报告单据作为原始文件之一应齐全，检查结果应及时录入至eCRF中。 此外，原始数据还包括：自动化仪器记录或生成的数据的原始打印、照相底片、X光片、心电图记录、受试者日志卡等。此类文件都必须至少表明受试者编号和实施操作的日期。如有可能，对于这些记录的医学评价应该有必要的文件记录，文件由研究者签署姓名和日期。这些原始文件中的信息都应该及时录入eCRF中。 1.2CRF的审核 研究者及其指定人员应及时完成eCRF的填写、审核并提交。研究者或数据录入人员（CRC）应及时回复来自监查员、数据管理员以及医学审核人员的质疑。在数据清理完成后，研究者对填写完毕的eCRF签名确认。 1.3数据监查和稽查 必须允许申办方的授权代表（如监查员、稽查员等）定期拜访所有研究中心场所，评价数据的质量以及研究是否完整、可靠。他们将现场审核研究记录，将这些记录与原始文件直接比对，与研究者讨论研究的实施情况，确认研究设施是否仍符合要求。 监查内容：是否遵循试验方案；所有CRF填写是否正确、完整，且与研究病历和实验室检查报告单等原始文件是否一致，数据有无错误或遗漏等。监查员将按照监查计划，对临床数据库中的试验数据进行完整性、一致性和准确性审查，并与研究人员对问题数据进行讨论，必要时研究人员进行补充或更正。确保eCRF中的数据与原始数据的一致性，该过程也被称为原始数据核查（SDV）。 此外，政府部门的检查人员也可能会对研究进行评价，必须允许这些人员查阅eCRF、原始文件和其他研究文件，也必须允许他们检查研究设施。稽查报告必须保密。如果政府部门计划进行检查，研究者必须立即通知申办方，并迅速将检查报告提供给申办方 2.数据管理 2.1建立EDC数据库 数据管理员按照研究方案建立研究数据采集系统及数据库，并在第1例受试者入组前提供上线使用。使用前，所有EDC用户需得到所需的培训并获得登陆系统的相应账号（研究机构人员接受过培训后，才能登陆EDC系统）。 2.2数据录入与核查 研究者或临床协调员（CRC）应按照访视流程的要求以及eCRF填写指南将数据输入EDC系统中。提交eCRF后，监查员、数据管理员以及医学人员应对数据进行逐一审核，审核中的问题以质疑的形式要求研究者或CRC回答。清理完毕后，eCRF需研究者签字确认。 2.3数据库锁定 临床试验完成后，由研究负责人、申办者、统计专家和数据管理员共同进行统计分析前的审核，其重要内容就是确定每个病例归属的分析数据集、缺失值的判断及离群值的处理等。 经审核认为所建立的数据库正确无误后，对数据库进行锁定。数据库锁定后的数据需妥善保存备查，数据库交统计专家进行统计分析。 在CRA的SDV完结之后，数据管理人员和医学人员将对数据库的全部数据进行最后的质量控制，汇总试验进行中出现的所有方案偏移和方案违背的事件，召开数据核查会。数据库中的数据达到质量要求后，将进行数据库的锁定，数据管理人员将导出数据供统计部门进行数据分析。

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

Data Management Methods 1. Data Recording In this study, electronic Case Report Forms (eCRFs) will be used for the collection and management of research data. Researchers must retain all research records and original documents for as long as possible, following the requirements of relevant regulations, guidelines, institutional protocols, or the sponsor's specified duration, whichever is longer. Before destroying any records related to the study, researchers must consult with the sponsor. If a researcher withdraws from the study (e.g., due to job changes, retirement, etc.), the records should be transferred to a designated person recognized by the relevant authorities, such as another researcher. Written notification must be provided to the sponsor regarding such transfer. 1.1 eCRF Completion Clinical research data will be collected using an Electronic Data Capture (EDC) system. Every person who can electronically sign the eCRF must meet the training requirements set by the sponsor and can only log in to the electronic data capture system using their own dedicated user account provided by the sponsor. User accounts should not be shared with others or assigned to other personnel. Completion: Data in the eCRF should be derived from original medical records, laboratory reports, and other source documents, and should match the information in the original documents. Any observations or examination results in the study should be promptly, accurately, completely, clearly, consistently, and truthfully recorded in the eCRF without arbitrary changes. All items in the CRF must be completed, with no empty or missing fields. Modifications: If necessary, when making corrections to the eCRF, the reasons for the data modifications should be filled in according to system prompts. The system's logic checks will verify the integrity and consistency of the clinical trial data entered into the EDC system and provide error messages for problematic data. Researchers or data entry personnel (CRC) can modify or explain the problematic data and raise queries multiple times until the issues are resolved. Laboratory examinations: The researcher should conduct various examinations based on the scheduled visit time windows, collect, enter, and report subject information and data, and ensure that laboratory examination reports, as one of the original documents, are complete. The examination results should be promptly entered into the eCRF. In addition, original data includes printouts from automated instruments, photographs, X-rays, ECG records, subject diary cards, and others. These documents should indicate at least the subject number and the date of the conducted operation. If possible, necessary documentation should accompany the medical assessment of these records, signed and dated by the researcher. The information from these original documents should be promptly entered into the eCRF. 1.2 CRF Review The researcher and designated personnel should promptly complete the eCRF, review it, and submit it. The researcher or data entry personnel (CRC) should respond promptly to queries from monitors, data managers, and medical reviewers. After data cleaning is completed, the researcher should sign and confirm the completed eCRF. 11.1.3 Data Monitoring and Auditing Authorized representatives of the sponsor, such as monitors and auditors, must be allowed to visit all research sites regularly to assess data quality and the completeness and reliability of the study. They will conduct on-site audits of research records, directly compare these records with the original documents, discuss the implementation of the study with the researcher, and confirm if the research facilities still meet the requirements. Monitoring content: Compliance with the study protocol, correctness and completeness of all CRF entries, consistency with the original documents such as medical records and laboratory reports, and presence of any data errors or omissions. Monitors will review the integrity, consistency, and accuracy of the trial data in the clinical database according to the monitoring plan. They will discuss problematic data with the researchers and request supplementary information or corrections when necessary. The process of ensuring the consistency between the data in the eCRF and the original data is also known as source data verification (SDV). In addition, government inspectors may also evaluate the study and must be allowed to access the eCRF, original documents, and other study files, as well as inspect the research facilities. The inspection reports must be kept confidential. If government authorities plan to conduct an inspection, the researcher must immediately notify the sponsor and promptly provide the inspection report to the sponsor. 2. Data Management 2.1 Establishment of EDC Database The data manager will establish the research data collection system and database according to the study protocol and make it available online before the enrollment of the first subject. Before using the system, all EDC users must receive the required training and obtain the corresponding account to log into the system (only trained personnel from the research institution can access the EDC system). 2.2 Data Entry and Verification The researcher or clinical coordinator (CRC) should enter data into the EDC system following the visit procedures and eCRF completion guidelines. After submitting the eCRF, monitors, data managers, and medical personnel should conduct individual reviews of the data, raising queries in the form of questions that require responses from the researcher or CRC. After the data cleaning process is completed, the researcher must sign and confirm the eCRF. 2.3 Database Locking After the completion of the clinical trial, the principal investigator, sponsor, statistical experts, and data managers will jointly review the database before statistical analysis. This review includes determining the analysis datasets for each case, determining missing values, and handling outliers. Once it is determined that the established database is correct and accurate, the database is locked. The locked data must be properly stored for reference, and the database is handed over to the statistical experts for statistical analysis. After the completion of the CRA's source data verification, the data management team and medical personnel will perform the final quality control on the entire database, summarizing all protocol deviations and violations that occurred during the trial, and holding a data verification meeting. After the data in the database meets the quality requirements, the database is locked, and the data management team exports the data for analysis by the statistical department.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

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  2023-12-25 17:41:49