ChiCTR2600120620 版本V1.0 版本创建时间2026/03/17 15:46:29 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：

 ChiCTR2600120620 

最近更新日期：

Date of Last Refreshed on：

 2026-03-17 15:46:23 

注册时间：

Date of Registration：

 2026-03-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

重复低强度红光照射对正常眼压性青光眼的短期疗效观察

Public title：

Short-Term Efficacy of Repeated Low-Intensity Red Light Therapy in Normal-Tension Glaucoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复低强度红光照射对正常眼压性青光眼的短期疗效观察

Scientific title：

Short-Term Efficacy of Repeated Low-Intensity Red Light Therapy in Normal-Tension Glaucoma

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：

樊宁 

研究负责人：

樊宁 

Applicant：

Fan Ning 

Study leader：

Fan Ning 

申请注册联系人电话：

Applicant telephone：

 +86 755 23959563

研究负责人电话：

Study leader's
telephone：

+86 13823504880

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：

 szfanning@126.com

研究负责人电子邮件：

Study leader's E-mail：

 szfanning@126.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：

中国广东省深圳市福田区泽田路18号

研究负责人通讯地址：

中国广东省深圳市福田区泽田路18号

Applicant address：

18 Zetian Road, Futian District, Shenzhen, Guangdong, China

Study leader's address：

18 Zetian Road, Futian District, Shenzhen, Guangdong, 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：

深圳市眼科医院

Applicant's institution：

Shenzhen Eye Hospital

研究负责人所在单位：

深圳市眼科医院

Affiliation of the Leader：

Shenzhen Eye Hospital

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：

 2025KYPJ091

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：

深圳市眼科医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shenzhen Eye Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-12 00:00:00

伦理委员会联系人：

张晓铃

Contact Name of the ethic committee：

Zhang Xiaoling

伦理委员会联系地址：

中国广东省深圳市福田区泽田路18号

Contact Address of the ethic committee：

18 Zetian Road, Futian District, Shenzhen, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 755 23959627

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 szehec@126.com

研究实施负责（组长）单位：

深圳市眼科医院

Primary sponsor：

Shenzhen Eye Hospital

研究实施负责（组长）单位地址：

中国广东省深圳市福田区泽田路18号

Primary sponsor's address：

18 Zetian Road, Futian District, Shenzhen, Guangdong, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

深圳市眼科医院

具体地址：

中国广东省深圳市福田区泽田路18号

Institution
hospital：

Shenzhen Eye Hospital

Address：

18 Zetian Road, Futian District, Shenzhen, Guangdong, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded

研究疾病：

正常眼压性青光眼  

Target disease：

Normal-tension glaucoma

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

探究短期重复低强度红光照射对正常眼压性青光眼患者眼底血流的影响。  

Objectives of Study：

Exploring the short-term effects of repeated low-intensity red light therapy on fundus blood flow in patients with normal-tension glaucoma.

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. 年龄在18-50岁； 2. 既往确诊为正常眼压性青光眼，既往检查资料满足以下诊断条件：(1) 既往未经治疗的眼压以及24 h眼压波动和峰值均<=21 mmHg；(2) 具有青光眼视神经病变，定义为以下特征的两个或以上: 1) 杯盘比增加，C/D>0.5; 2) 杯盘比不对称，C/D差异>0.2; 3) 视盘出血; 4) 与视野缺损对应的神经视网膜边缘切迹或神经纤维层变薄；(3) 双眼房角为开角；(4) 典型的青光眼视野缺损（Humphrey自动视野仪），定义为以下特征中的一个或以上: 1) 平均缺陷和模式标准偏差超出95% CI；2) 青光眼半场测试结果超出正常范围；3) 模式偏差图中至少有三个点P值<0.05，且至少有一个点P值<0.01； 3. 单眼或双眼晚期青光眼，定义为视野平均缺损值<=-12 dB或C/D>=0.7。

Inclusion criteria

1. Age between 18 and 50 years; 2. Previously diagnosed with normal-tension glaucoma based on the following criteria: (1) Previously untreated intraocular pressure, 24-hour IOP fluctuation, and peak IOP were all <=21 mmHg; (2) Presence of glaucomatous optic neuropathy, defined as two or more of the following: 1) Increased cup-to-disc ratio, C/D > 0.5; 2) Asymmetric cup-to-disc ratio, C/D difference > 0.2; 3) Optic disc hemorrhage; 4) Neuroretinal rim notching or retinal nerve fiber layer thinning corresponding to visual field defect; (3) Open angles in both eyes on gonioscopy; (4) Typical glaucomatous visual field defect (Humphrey Field Analyzer), defined as one or more of the following: 1) Mean Deviation and Pattern Standard Deviation outside 95% confidence interval; 2) Glaucoma Hemifield Test results outside normal limits; 3) At least three points with P < 0.05 on the pattern deviation plot, with at least one point having P < 0.01; 3. Advanced glaucoma in one or both eyes, defined as mean deviation in the visual field <= -12 dB or cup-to-disc ratio >= 0.7.

排除标准：

1. 双眼屈光度>+3.00 D或<-6.00 D； 2. 双眼眼轴＜22.00 mm； 3. 系统性疾病，如高血压、糖尿病、心血管疾病等； 4. 眼科手术史或眼外伤史； 5. 患有其他可能导致视野缺损或视神经损伤的疾病； 6. 视野检查的结果不可靠，如固定误差大于20%，假阳性大于15%，假阴性大于33%； 7. 红光照射后像时间>5分钟。

Exclusion criteria：

1. Spherical equivalent refractive error in both eyes > +3.00 D or < -6.00 D; 2. Axial length of both eyes < 22.00 mm; 3. Presence of systemic diseases such as hypertension, diabetes, or cardiovascular conditions; 4. History of ocular surgery or ocular trauma; 5. Presence of other diseases that may cause visual field defects or optic nerve damage; 6. Unreliable visual field test results, such as fixation losses > 20%, false positives > 15%, or false negatives > 33%; 7. Visual afterimages lasting longer than 5 minutes following red light exposure.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-06 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

第一阶段自身对照组

样本量：

 10

Group：

The first stage is the self-control group

Sample size：

干预措施：

所有入组的 NTG 患者在原各自的眼压控制方案不变的情况下，接受为期 28 天的 RLRL 治疗。选择视野缺损较严重眼为治疗组，视野缺损较轻眼为对照组。若双眼视野缺损程度相同，则选择右眼为治疗眼；对侧眼为对照眼。RLRL 设备(苏州宣嘉光电科技有限公司提供)通过半导体激光二极管发射 650+/-10nm 波长的红光，从瞳孔到眼底的照明强度为 1600lux，根据制造商的计算，该设备提供的光功率为 2.00+/-0.50mW，经4mm 瞳孔的能量为 0.29mW。采用现行的近视红光治疗方案：患者将被指导每天使用两次RLRL 设备照射治疗眼，每次三分钟，两次治疗之间间隔至少 4 小时，对侧眼将使用不透明眼罩遮盖。随访在治疗后第 7、14、21 和 28 天进行

干预措施代码：

Intervention：

All enrolled NTG patients received 28-day RLRL treatment while maintaining their original intraocular pressure control regimens. Eyes with more severe visual field defects were selected as the treatment group, and eyes with milder visual field defects were selected as the control group. If the degree of visual field defect in both eyes is the same, the right eye will be selected as the treated eye. The contralateral eye is the control eye. The RLRL device (provided by Suzhou Xuanjia Optoelectronic Technology Co., LTD.) emits red light with a wavelength of 650+/-10nm through a semiconductor laser diode. The illumination intensity from the pupil to the fundus is 1600lux. According to the manufacturer's calculation, the optical power provided by this device is 2.00+/-0.50mW. The energy passing through a 4mm pupil is 0.29mW. The current red light treatment plan for myopia will be adopted: Patients will be instructed to use the RLRL device to irradiate the treated eye twice a day, each time for three minutes, with an interval of at least 4 hours between the two treatments. The opposite eye will be covered with an opaque eye mask. Follow-up was conducted on the 7th, 14th, 21st and 28th days after treatment

Intervention code：

组别：

第二阶段自身对照组

样本量：

 20

Group：

The second stage is the self-control group

Sample size：

干预措施：

根据第一阶段研究数据决定研究是否进行第二阶段研究（纳入剩余 20 例受试者）。

干预措施代码：

Intervention：

Based on the data from the first stage of the research, it will be decided whether to conduct the second stage of the research (including the remaining 20 subjects).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 深圳市眼科医院 

单位级别：

 三级甲等 

Institution
hospital：

Shenzhen Eye Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

治疗28天时的视盘周边血管密度变化

指标类型：

主要指标

Outcome：

Changes in peripapillary vessel density after 28 days of treatment

Type：

Primary indicator

测量时间点：

治疗28天时

测量方法：

使用视微OCTA进行视盘周围区域扫描，并使用其内置分析软件采集视盘周边血管密度，其中视盘周围区域定义为在视盘边界向外扩展的700μm的椭圆环形区域。

Measure time point of outcome：

At day 28 of treatment

Measure method：

The optic disc area was scanned using Visee OCTA, and the peripapillary vessel density was measured using its built-in analysis software, with the peripapillary region defined as an elliptical annular area extending 700 μm outward from the optic disc boundary.

指标中文名：

治疗28天时的视盘周边神经纤维层厚度变化

指标类型：

次要指标

Outcome：

Changes in peripapillary retinal nerve fiber layer thickness after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

使用视微OCTA内置的OCT扫描模式进行视盘周围视网膜结构扫描，并使用其内置分析软件采集视盘周边神经纤维层厚度，其中视盘周围区域定义为在视盘边界向外扩展的700μm的椭圆环形区域。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Using the OCT scanning mode built into the Visee OCTA, peripapillary retinal structure was scanned, and the peripapillary retinal nerve fiber layer thickness was measured using its built-in analysis software, with the peripapillary region defined as an elliptical annular area extending 700 μm outward from the optic disc boundary.

指标中文名：

治疗28天时的未矫正视力、最佳矫正视力变化

指标类型：

次要指标

Outcome：

Changes in uncorrected visual acuity and best-corrected visual acuity after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

采用Tumbling E ETDRS视力表（Precision Vision, Villa Park, Illinois, USA）测量4m处的双眼裸眼远视力和最佳矫正远视力。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Binocular uncorrected distance visual acuity and best-corrected distance visual acuity were measured at 4 meters using the Tumbling E ETDRS chart (Precision Vision, Villa Park, Illinois, USA).

指标中文名：

治疗28天时的屈光度变化

指标类型：

次要指标

Outcome：

Changes in refractive error after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

使用台式自动验光仪进行小瞳下双眼自动验光，测量双眼的球镜度数、柱镜度数和轴向，每眼各测3次，要求每次球镜、柱镜度数相差不超过+0.5D，取3次读数均值。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Using a table-mounted automated refractor, binocular auto-refraction was performed under non-cycloplegic conditions. The spherical power, cylindrical power, and axis were measured for both eyes. Each eye was measured three times, requiring that the difference in spherical and cylindrical power between measurements did not exceed +/-0.5 D. The average of the three readings was calculated.

指标中文名：

治疗28天时的眼轴变化

指标类型：

次要指标

Outcome：

Changes in axial length after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

使用IOLMaster眼球生物学测量仪采集受试者的角膜曲率、前房深度、眼轴长度等生物学参数。眼轴测量连续5次，取平均值。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Using the IOLMaster optical biometer, biometric parameters including corneal curvature, anterior chamber depth, and axial length were measured. Axial length was measured five consecutive times, and the average value was calculated.

指标中文名：

治疗28天时的黄斑区血管密度变化

指标类型：

次要指标

Outcome：

Changes in macular vascular density after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

使用视微OCTA进行黄斑区（4.5x4.5mm区域）扫描，并使用其内置分析软件采集黄斑区血管密度。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Using Visee OCTA, the macular region (4.5 x 4.5 mm area) was scanned, and the macular vessel density was measured using its built-in analysis software.

指标中文名：

治疗28天时的眼压及眼灌注压变化

指标类型：

次要指标

Outcome：

Changes in intraocular pressure and ocular perfusion pressure after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

局部麻醉后使用荧光素染色剂进行角膜染色，在裂隙灯下使用Goldmann眼压计测量眼压。使用自动血压计测量受试者坐位右上臂收缩压SBP、舒张压DBP，计算眼灌注压，公式为：平均动脉压MAP=1/3(2*DBP+SBP)，眼灌注压=2/3(MAP-眼压)。

Measure time point of outcome：

At day 28 of treatment

Measure method：

After topical anesthesia, the cornea was stained with fluorescein, and intraocular pressure was measured using a Goldmann applanation tonometer under a slit lamp. An automated sphygmomanometer was used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP) in the subject's right upper arm in a seated position. The ocular perfusion pressure was calculated using the formulas: Mean Arterial Pressure (MAP) = 1/3(2*DBP + SBP), and Ocular Perfusion Pressure = 2/3(MAP - Intraocular

指标中文名：

治疗28天时的脉络膜厚度、脉络膜血管指数变化

指标类型：

次要指标

Outcome：

Changes in choroidal thickness and choroidal vascular index after 28 days of treatment

Type：

Secondary indicator

测量时间点：

治疗28天时

测量方法：

使用视微OCTA进行黄斑区（4.5x4.5mm区域）扫描，并使用其内置分析软件采集黄斑中心凹处脉络膜厚度及黄斑区脉络膜血管指数。

Measure time point of outcome：

At day 28 of treatment

Measure method：

Using Visee OCTA, the macular region (4.5 x 4.5 mm area) was scanned, and the choroidal thickness at the fovea and the choroidal vascular index in the macular region were measured using its built-in analysis software.

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse Events

Type：

Secondary indicator

测量时间点：

28天治疗期间

测量方法：

记录治疗过程中任何报告的不良事件。其中严重不良事件定义为：视力突然下降两行以上、视野中心出现暗点、或OCT图像中出现任何结构损伤。

Measure time point of outcome：

During the 28-day treatment period

Measure method：

Any adverse events reported during the treatment were recorded. A serious adverse event was defined as a sudden decrease in visual acuity of two lines or more, the appearance of a scotoma in the central visual field, or any structural damage observed in the OCT image.

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 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：

无

Blinding：

None

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）：

原始数据将通过国家生物信息中心(CNCB)生物数据递交系统(BIG Sub)共享，网址：https://ngdc.cncb.ac.cn/gsub/。预计共享时间：研究结束后6个月内。

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

The raw data will be shared via the China National Center for Bioinformation (CNCB) BIG Submission Portal (BIG Sub) at https://ngdc.cncb.ac.cn/gsub/, with the data sharing expected to occur within six months after the conclusion of the study.

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：

原始数据通过病例记录表采集，原始数据管理由专人负责。

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

The original data are collected through the case record form and managed by a specially assigned person.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-17 15:46:23