ChiCTR2600123219 版本V1.0 版本创建时间2026/04/22 17:41:02 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：

 ChiCTR2600123219 

最近更新日期：

Date of Last Refreshed on：

 2026-04-22 17:40:22 

注册时间：

Date of Registration：

 2026-04-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

眼部熏蒸时眼睑开合状态对脂质异常型干眼症物理治疗疗效的影响

Public title：

Effect of Eyelid Position During Ocular Steam Therapy on Treatment Outcomes in Lipid-Deficient Dry Eye Disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

眼部熏蒸时眼睑开合状态对MGD型干眼症物理治疗疗效的影响

Scientific title：

Effect of Eyelid Position During Ocular Steam Therapy on Treatment Outcomes in Lipid-Deficient Dry Eye Disease

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：

赵曾燕 

研究负责人：

张青 

Applicant：

Zengyan Zhao 

Study leader：

Qing Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 152 1283 2220

研究负责人电话：

Study leader's
telephone：

+86 153 7505 6648

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：

 2445012170@stu.ahmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhangqing@ahmu.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：

安徽省合肥市经济技术开发区芙蓉路678号

研究负责人通讯地址：

安徽省合肥市经济技术开发区芙蓉路678号

Applicant address：

No. 678 Furong Road, Economic and Technological Development Zone, Hefei City, Anhui Province

Study leader's address：

No. 678 Furong Road, Economic and Technological Development Zone, Hefei City, Anhui Province

申请注册联系人邮政编码：

Applicant postcode：

 230601

研究负责人邮政编码：

Study leader's postcode：

 230601

申请人所在单位：

安徽医科大学第二附属医院

Applicant's institution：

The Second Hospital of Anhui Medical University

研究负责人所在单位：

安徽医科大学第二附属医院

Affiliation of the Leader：

The Second Hospital of Anhui Medical University

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：

 YX2025-250

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：

安徽医科大学第二附属医院研究伦理委员会

Name of the ethic committee：

The Second Hospital of Anhui Medical University,Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-30 00:00:00

伦理委员会联系人：

张静

Contact Name of the ethic committee：

Jing Zhang

伦理委员会联系地址：

安徽省合肥市经济技术开发区芙蓉路678号

Contact Address of the ethic committee：

No. 678 Furong Road, Economic and Technological Development Zone, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 551 6380 6061

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：

安徽医科大学第二附属医院

Primary sponsor：

The Second Hospital of Anhui Medical University

研究实施负责（组长）单位地址：

安徽省合肥市经济技术开发区芙蓉路678号

Primary sponsor's address：

No. 678 Furong Road, Economic and Technological Development Zone, Hefei City, Anhui Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

安徽医科大学第二附属医院

具体地址：

安徽省合肥市经济技术开发区芙蓉路678号

Institution
hospital：

The Second Hospital of Anhui Medical University

Address：

No. 678 Furong Road, Economic and Technological Development Zone, Hefei City, Anhui Province

经费或物资来源：

安徽省卫生健康科研项目（AHWJ2023A20229）

Source(s) of funding：

Anhui Province Health and Wellness Research Project (AHWJ2023A20229)

研究疾病：

MGD型干眼症  

Target disease：

MGD-type dry eye

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究MGD型干眼症患者的眼睑开合状态对其眼部熏蒸治疗疗效的影响及何种状态可以提高治疗疗效  

Objectives of Study：

Investigate the effect of eyelid opening and closing status on the efficacy of ocular fumigation treatment in patients with MGD-type dry eye and which status can improve treatment efficacy

药物成份或治疗方案详述：

采取抛硬币法，将100名受试者的左右眼随机分入试验组和对照组，治疗1次/周，连续4次。试验组：予静脉输液贴封合眼睑，闭眼状态下行眼部熏蒸联合睑板腺按摩治疗；对照组：予眼睑自然睁开，睁眼状态下行眼部熏蒸联合睑板腺按摩治疗。 在超声雾化干眼治疗仪水槽中加入生理盐水作为熏蒸药液，打开主机，雾化温度上升，主机连接眼罩，嘱患者带上眼罩，熏蒸温度维持在45℃，持续15min后行睑板腺按摩，在表麻下使用睑板腺按摩镊分别对受试者双眼上下睑板腺进行按摩。上述治疗均由同一医师完成，1次/周。 本研究时间共4周，在治疗前、首次治疗后以及末次治疗后即刻对受试者进行一系列评估，包括眼表疾病指数评分（OSDI）、视觉模拟评分（VAS）、泪膜破裂时间（TBUT）、角膜荧光素染色、泪液分泌实验、脂质层厚度、睑板腺缺失评分、睑板腺排出能力评估、睑酯性状评估以及眼睑温度等。这些评估指标旨在全面评估治疗效果，包括症状改善、泪膜稳定性、角膜健康状况、泪液分泌量和质量以及睑板腺功能。  

Description for medicine or protocol of treatment in detail：

Using the coin toss method, the left and right eyes of 100 subjects were randomly assigned to the experimental group and the control group, treated once a week for 4 consecutive weeks. Experimental group: intravenous infusion was applied with eyelid sealing, and eye steaming combined with meibomian gland massage was performed with eyes closed; control group: eyelids were kept naturally open, and eye steaming combined with meibomian gland massage was performed with eyes open. Physiological saline was added to the water tank of the ultrasonic nebulization device for dry eye treatment as the steaming solution. The main unit was turned on, the nebulization temperature was increased, the device was connected to the eye mask, and patients were instructed to wear the eye mask. The steaming temperature was maintained at 45°C, and after 15 minutes of steaming, meibomian gland massage was performed. Under topical anesthesia, meibomian gland massage forceps were used to massage the upper and lower meibomian glands of both eyes of the subjects. All treatments were performed by the same physician, once a week. The study lasted a total of 4 weeks. Subjects underwent a series of assessments before treatment, immediately after the first treatment, and immediately after the last treatment, including the Ocular Surface Disease Index (OSDI), Visual Analogue Scale (VAS), Tear Break-Up Time (TBUT), corneal fluorescein staining, tear secretion test, lipid layer thickness, meibomian gland dropout score, meibomian gland expressibility evaluation, meibum quality assessment, and eyelid temperature. These evaluation indicators aim to comprehensively assess the therapeutic effect, including symptom improvement, tear film stability, corneal health status, tear secretion quantity and quality, and meibomian gland function. 

纳入标准：

MGD型干眼症受试者必须满足以下所有标准，才有资格入组本实验： 1.符合睑板腺功能障碍的诊断标准； 参照我国2017年MGD诊疗专家共识： (1)睑缘及睑板腺开口异常 (2)睑板腺分泌异常 (3)具有干燥感、异物感、眼痛、眼痒、视力波动等眼部症状 (4)脂质层增厚 (5)睑板腺缺失 具备(1)或(2)中的任何一项，结合 3)则可诊断MGD，4)、5)为加强诊断指标。 2.符合干眼症的诊断标准： 参照《中国干眼专家共识：检查和诊断(2020)年》诊断 (1)具有眼部干涩、痒干、异物感、灼热感、酸胀感、视疲劳、眼睛红肿、微光流泪、疼痛、实力改变等眼部主观症状之一或多项； (2)泪膜破裂时间（TBUT）≤10s； (3)泪液分泌实验（SIT）≤10mm/5min； (4)角膜荧光素染色（CFS）阳性； (5)分级：1)轻度：裂隙灯显微镜下检查无明显眼表损伤体征（角膜荧光素染色点<5个），TBUT在2s及以上。2)中度：裂隙灯显微镜下检查角膜损伤范围不超过2个象限和（或）角膜荧光素染色点≥5个且<30个，TBUT在2s及以上。3)重度：裂隙灯显微镜检查角膜损伤范围2个象限及以上和（或）角膜荧光染色点≥30个，TBUT<2 s。角膜荧光素染点融合成粗点、片状或伴有丝状物。 3.年龄在18-90岁之间； 4.对本研究所采用的实验方法无不良反应者； 5.患者本人知情并签署同意书

Inclusion criteria

Subjects with MGD-related dry eye disease are eligible for enrollment in this study only if they meet all of the following criteria: Meet the diagnostic criteria for Meibomian Gland Dysfunction (MGD) 1.In accordance with the 2017 Chinese Expert Consensus on Diagnosis and Treatment of MGD: (1) Abnormal eyelid margin and Meibomian gland orifices; (2) Abnormal Meibomian gland secretion; (3) Ocular symptoms including dryness, foreign body sensation, ocular pain, ocular pruritus, visual fluctuation, etc; (4) Thickened lipid layer; (5) Meibomian gland atrophy/loss; MGD can be diagnosed when either criterion (1) or (2) is satisfied, combined with criterion (3). Criteria (4) and (5) are supplementary diagnostic indicators. 2.Meet the diagnostic criteria for dry eye diseaseDiagnosed in accordance with the Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020):(1) Presence of one or more subjective ocular symptoms including dry eye, dry itching, foreign body sensation, burning sensation, ocular distension, visual fatigue, ocular redness, photophobia with lacrimation, ocular pain, visual acuity changes, etc.(2) Tear Break-Up Time (TBUT) ≤10 seconds(3) Schirmer I Test (SIT) <=10 mm/5 min(4) Positive Corneal Fluorescein Staining (CFS)(5) Severity grading: Mild: No obvious ocular surface lesions on slit-lamp examination (<5 corneal fluorescein staining spots), TBUT >=2 s; Moderate: Corneal lesions involving no more than 2 quadrants and/or ≥5 but <30 corneal fluorescein staining spots on slit-lamp examination, TBUT >=2 s; Severe: Corneal lesions involving >=2 quadrants and/or >=30 corneal fluorescein staining spots on slit-lamp examination, TBUT <2 s; corneal fluorescein staining spots coalesce into coarse spots, patches, or are accompanied by filaments. 3.Aged between 18 and 90 years old; 4.No adverse reactions to the experimental methods adopted in this study; 5.The subject fully understands the study and has signed an informed consent form.

排除标准：

符合以下任一标准的受试者均从本实验中排除： 1.全身患有严重疾病，如心脑血管疾病，肝肾功能损害，血液系统疾病者等； 2.双眼中任何一眼患有结膜炎、角膜炎、巩膜炎、虹膜炎等眼部炎症性疾病及眼眶组织结构异常，合并全身免疫性疾病者； 3.处于妊娠、哺乳期的女性受试者，或在研究期间和研究结束后3个月内有妊娠意向、不同意采取有效避孕措施的男、女性受试者； 4.近3个月内曾做眼部手术者； 5.筛选前3个月内参加过其他临床试验，或在研究期间试图参加其他临床实验者。

Exclusion criteria：

Subjects meeting any one of the following criteria shall be excluded from this study: 1.Subjects with severe systemic diseases, including cardiovascular and cerebrovascular diseases, hepatic and renal dysfunction, hematological diseases, etc; 2.Subjects with inflammatory ocular diseases such as conjunctivitis, keratitis, scleritis, iritis in either eye, orbital structural abnormalities, or complicated with systemic autoimmune diseases; 3.Female subjects who are pregnant or breastfeeding; male and female subjects who plan to become pregnant during the study period or within 3 months after the completion of the study, or who refuse to adopt effective contraceptive measures; 4.Subjects who have undergone ocular surgery within the past 3 months; 5.Subjects who have participated in other clinical trials within 3 months prior to screening, or who intend to participate in other clinical trials during the study period.

研究实施时间：

Study execute time：

从 From 2025-09-30 00:00:00至 To 2027-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-23 00:00:00 至 To 2026-08-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 50

Group：

Experimental group

Sample size：

干预措施：

闭眼状态下行眼部熏蒸联合睑板腺按摩治疗

干预措施代码：

Intervention：

Treatment with ocular steaming combined with meibomian gland massage in a closed-eye state

Intervention code：

组别：

对照组

样本量：

 50

Group：

Experimental group

Sample size：

干预措施：

予眼睑自然睁开，睁眼状态下行眼部熏蒸联合睑板腺按摩治疗

干预措施代码：

Intervention：

Let the eyelids naturally open, performing eye steam therapy combined with meibomian gland massage in the eyes-open state

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安徽医科大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Hospital of Anhui Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 合肥 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 芜湖市眼科医院 

单位级别：

 三级 

Institution
hospital：

Wuhu Ophthalmology Hospital

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 六安市人民医院 

单位级别：

 三甲 

Institution
hospital：

Lu'an People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 阜阳市人民医院 

单位级别：

 三甲 

Institution
hospital：

Fuyang People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 安庆市立医院 

单位级别：

 三甲 

Institution
hospital：

Anqing Municipal Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 怀宁县医院 

单位级别：

 三级 

Institution
hospital：

Huaining County Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

临床疗效

指标类型：

主要指标

Outcome：

Clinical efficacy

Type：

Primary indicator

测量时间点：

基线，4周

测量方法：

临床疗效指标参照《中国干眼专家共识：治疗（2020年）》

Measure time point of outcome：

Baseline, 4 weeks

Measure method：

Clinical efficacy indicators refer to the "Chinese Dry Eye Expert Consensus: Treatment (2020)"

指标中文名：

眼表疾病指数

指标类型：

次要指标

Outcome：

Ocular surface disease index,OSDI

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，采用OSDI 评估两组患者的临床症状，此量表主要包括眼部症状、视觉相关功能和环境刺激因子3部分，共12个项目，OSDI 评分=（所回答问卷项目得分综合）×100/（回答问卷项目数）×4，总分范围0-100分，分数越高表示眼部症状越重

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, the clinical symptoms of the two groups of patients were assessed using the OSDI. This scale mainly includes three parts: ocular symptoms, vision-related function, and environmental triggers, with a total of 12 items. The OSDI score = (sum of the scores of answered questionnaire items) × 100 / (number of answered items × 4). The total score ranges from 0 to 100, with higher scores indicating more severe ocular symptoms.

指标中文名：

视觉模拟评分

指标类型：

次要指标

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，要求受试者根据其当下眼部不适的程度对以下7项眼部症状的每一项单独评分：眼部干涩感、异物感、烧灼感、疲劳感、不适感、眼红、视力波动。由受试者主观评价每一项症状，总分0-100分，0分代表无不适，100分代表最大不适

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, subjects were required to rate each of the following seven eye symptoms separately according to the current level of their eye discomfort: dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, and vision fluctuation. Each symptom was subjectively evaluated by the subjects, with a total score of 0-100, where 0 represents no discomfort and 100 represents maximum discomfort.

指标中文名：

泪膜破裂时间

指标类型：

次要指标

Outcome：

Tear break-uptime,TBUT

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，使用生理盐水浸润荧光素钠试纸，涂抹于患者下睑处，指导患者自然眨眼三次后停止眨眼，利用裂隙灯钴蓝光进行观察，分别记录两组患眼从最后一次瞬目后睁眼到第一个干燥斑出现的时间，重复检测3次，取平均值；

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, infiltrate sodium fluorescein test strips with saline and apply to the patient's lower eyelid. Instruct the patient to blink naturally three times and then stop blinking. Observe using a slit-lamp cobalt blue light, and record the time from the last blink to the appearance of the first dry spot for the affected eyes in both groups. Repeat the test three times and take the average value.

指标中文名：

角膜荧光素染色

指标类型：

次要指标

Outcome：

Corneal fluorescein staining,CFS

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，在患者眼结膜囊内滴入1滴荧光素钠溶液，嘱患者眨眼数次，观察角膜内4个象限染色情况。

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, instill one drop of sodium fluorescein solution into the patient's conjunctival sac, instruct the patient to blink several times, and observe the staining in the four quadrants of the cornea.

指标中文名：

基础泪液分泌试验

指标类型：

次要指标

Outcome：

Schirmer test,SIt

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，统计两组患眼的泪液分泌量

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, the tear secretion of the eyes in both groups was measured; one end of the Schirmer I test strip was folded back 5 mm and placed in the lateral third of the lower conjunctival sac, avoiding contact with the cornea as much as possible, with the other end hanging naturally. Patients were instructed to gently close their eyes for 5 minutes, after which the strip was removed and the length of the wet portion was measured (normal range is 15 mm). The longer the wet leng

指标中文名：

睑板腺缺失评分

指标类型：

次要指标

Outcome：

Meibomian gland dropout score,MGDS

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，采用眼表分析仪于红外线下行睑板腺照相，获得睑板腺红外图像后进行评分：无睑板腺缺失（0分）；睑板腺缺失<1/3睑板面积（1分）；睑板腺缺失1/3～2/3睑板面积（2分）；睑板腺缺失>2/3睑板腺面积（3分）。单侧上下眼睑共计0～6分

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, an ocular surface analyzer was used to photograph the meibomian glands under infrared light. After obtaining infrared images of the meibomian glands, scoring was performed: no meibomian gland loss (0 points); meibomian gland loss <1/3 of the eyelid area (1 point); meibomian gland loss 1/3–2/3 of the eyelid area (2 points); meibomian gland loss >2/3 of the eyelid area (3 points). The total score for the upper and lower eyelids of one eye is 0–6 points.

指标中文名：

睑板腺排出能力评估

指标类型：

次要指标

Outcome：

Meibomian glands yielding liquid secretion, MGYLS

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，使用睑板腺评估仪(meibomian gland evaluator, MGE)进行MGYLS的检测。

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and at follow-up visits, the Meibomian Gland Evaluator (MGE) was used to assess MGYLS.

指标中文名：

睑酯性状评估

指标类型：

次要指标

Outcome：

Meibomian gland yielding secretion score, MGYSS

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，根据按压睑板腺时排出的睑酯性状进行评分，睑酯为清亮液体记为0分，为混浊液体记为1分，为混浊颗粒状物记为2分，为浓稠牙膏状记为3分，单侧上下睑总分为0～6分。

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, the quality of meibum expressed by pressing the meibomian glands was scored: clear liquid was scored as 0, cloudy liquid as 1, cloudy granular material as 2, and thick toothpaste-like material as 3. The total score for the upper and lower eyelids on one side ranged from 0 to 6.

指标中文名：

泪膜脂质层厚度

指标类型：

次要指标

Outcome：

Tear film lipid layer thickness,LLT

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，使用眼表分析仪记录受试者泪膜脂质层厚度，可分为3个等级，1级，脂质层薄，模糊、颜色灰暗；2级，脂质层正常，清晰、色彩丰富；3级，脂质层厚，高度清晰、色彩非常丰富。

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and during visits, the subject's tear film lipid layer thickness was recorded using a tear film analyzer, which can be divided into three grades: Grade 1, thin lipid layer, blurry and dull in color; Grade 2, normal lipid layer, clear and colorful; Grade 3, thick lipid layer, highly clear and very colorful.

指标中文名：

眼睑温度

指标类型：

次要指标

Outcome：

Eyelid temperature

Type：

Secondary indicator

测量时间点：

基线，1周，4周

测量方法：

于基线和访问时，待受试者熏蒸开始前与结束后，研究人员迅速翻转患者眼睑，暴露睑板，使用手持式红外温度计分别测量受试者睁眼状态下内眼睑温度以及静脉敷贴闭合眼睑状态下眼睑温度

Measure time point of outcome：

Baseline, 1weeks,4 weeks

Measure method：

At baseline and at the time of interview, before and after the fumigation of the subjects, the researchers quickly flipped the patients' eyelids to expose the tarsal plate, and measured the internal eyelid temperature of the subjects with open eyes and the eyelid temperature of the subjects with closed eyelids by intravenous application using a hand-held infrared thermometer

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 18 岁 years
最大 Max age 90 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）：

采取抛硬币法，将100名受试者的左右眼随机分入试验组和对照组

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

Use the coin toss method to randomly assign the left and right eyes of 100 subjects into the experimental group and the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究为一项开放标签研究，因治疗方式不同，不设盲。但所有眼科评估如OSDI、BUT、FL、SIL等评分均由盲态人员执行。

Blinding：

This study is an open-label study. Due to different treatment methods, it is not blinded. However, all ophthalmic evaluations such as OSDI, BUT, FL, SIL, and other scores are performed by blinded personnel.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

无

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

None

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：

在研究项目团队中设立研究员、监察员、数据管理员等不同岗位，并对参与者进行培训，研究者在采集数据时以受试者信息收集表的形式采集，保证数据的准确、完整与及时性。监察员根据原文件核查信息收集表中的数据，一旦发现其中有错误或差异，应通知研究者，并根据所发现的错误或差异，记录相应的质疑，以确保所有数据的记录和报告正确和完整。数据管理员应按照研究方案的要求，对数据标准进行管理，对发现的问题应及时清理，通过临床监察员向研究者发出疑问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改和确认。

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

In a research project team, different positions such as researchers, monitors, and data administrators are established, and participants are trained. Researchers collect data using subject information collection forms to ensure the accuracy, completeness, and timeliness of the data. Monitors verify the data in the collection forms against the original documents. If any errors or discrepancies are found, they should notify the researchers and record corresponding queries based on the errors or discrepancies to ensure that all data recording and reporting are correct and complete. Data administrators should manage data standards according to the requirements of the research protocol, promptly address any issues discovered, raise queries to researchers through clinical monitors, and researchers should respond and return answers as soon as possible. Data administrators then modify and confirm the data based on the researchers' responses.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-22 17:40:22