ChiCTR2600123549 版本V1.0 版本创建时间2026/04/27 18:01:48 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：

ChiCTR2600123549 

最近更新日期：

Date of Last Refreshed on：

2026-04-27 18:01:11 

注册时间：

Date of Registration：

2026-04-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

眼小医非接触式角膜知觉仪的重复性与一致性研究

Public title：

Study on the Repeatability and Consistency of the Dr.eye Non-Contact Corneal Aesthesiometer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

眼小医非接触式角膜知觉仪的重复性与一致性研究

Scientific title：

Study on the Repeatability and Consistency of the Dr.eye Non-Contact Corneal Aesthesiometer

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：

陈诺 

研究负责人：

赵泽林 

Applicant：

Nuo Chen 

Study leader：

Zelin Zhao 

申请注册联系人电话：

Applicant telephone：

+86 188 6828 5822

研究负责人电话：

Study leader's telephone：

+86 135 8786 6512

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：

1017002484@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zhaozelinwz@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：

浙江省温州市鹿城区学院西路270号

研究负责人通讯地址：

浙江省温州市鹿城区学院西路270号

Applicant address：

No. 270, Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang Province

Study leader's address：

No. 270, Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang Province

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：

温州医科大学附属眼视光医院

Applicant's institution：

Eye Hospital,WMU

研究负责人所在单位：

温州医科大学附属眼视光医院

Affiliation of the Leader：

Eye Hospital, Wenzhou Medical University

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：

温医大眼视光伦审2026研第088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：

温州医科大学附属眼视光医院伦理委员会

Name of the ethic committee：

Ethics committee of Eye Hospital of Wenzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-03-31 00:00:00

伦理委员会联系人：

谷佩秋

Contact Name of the ethic committee：

Gu PeiQiu

伦理委员会联系地址：

浙江省温州市鹿城区学院西路270号

Contact Address of the ethic committee：

No. 270, Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 577 88075582

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gupeiqiu@126.com

研究实施负责（组长）单位：

温州医科大学附属眼视光医院

Primary sponsor：

Eye Hospital, Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市鹿城区学院西路270号

Primary sponsor's address：

No. 270, Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属眼视光医院

具体地址：

浙江省温州市鹿城区学院西路270号

Institution
hospital：

Eye Hospital, Wenzhou Medical University

Address：

No. 270, Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang Province

经费或物资来源：

“医学高峰”专项经费

Source(s) of funding：

YN-YXGF2026

Target disease：

Neurotrophic Keratitis

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

评价眼小医非接触式角膜知觉仪的重复性、一致性与安全性，为该设备的临床应用提供客观依据，以期为角膜知觉检查提供一种新的可靠手段。  

Objectives of Study：

To evaluate the repeatability, consistency, and safety of the Dr.eye non-contact corneal aesthesiometer, so as to provide an objective basis for its clinical application, and to offer a new reliable method for corneal aesthesiometry.

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.健康组： (1)年龄>=18周岁，能够充分理解研究说明并配合完成全部主观检查项目； (2)充分了解本研究的目的、方法、潜在获益与风险后，自愿参与研究，并由本人签署书面知情同意书，依从性好，配合随访。 (3)经裂隙灯显微镜检查确认双眼无活动性眼表疾病，且无角膜知觉减退的临床证据。 2.神经营养性角膜炎患者组： (1)年龄>=18周岁，能够充分理解研究说明并配合完成全部主观检查项目； (2)充分了解本研究的目的、方法、潜在获益与风险后，自愿参与研究，并由本人签署书面知情同意书，依从性好，配合随访； (3)根据病史、体征及辅助检查结果，参照《中国神经营养性角膜炎诊断及治疗专家共识（2021年）》，临床诊断为神经营养性角膜炎；所有患者都需要经由温州医科大学附属眼视光医院角膜及眼表疾病专科医生在门诊明确诊断为“神经营养性角膜炎”。 (4)能够耐受检查过程中的气流刺激及机械刺激，即不处于急性期，无角膜穿孔风险。 (5)若为双眼发病，随机化方法确定单眼纳入研究；若为单眼发病，仅将患眼纳入研究，对侧健眼不纳入健康组。

Inclusion criteria

1.Healthy group: (1) Age >=18 years, able to fully understand the study instructions and cooperate in completing all subjective examination items; (2) After fully understanding the purpose, methods, potential benefits and risks of this study, voluntarily participate in the study, and personally sign the written informed consent form, with good compliance and cooperation with follow-up visits. (3) Confirmed by slit-lamp microscope examination that both eyes have no active ocular surface disease, and no clinical evidence of corneal hypoesthesia. 2.Neurotrophic keratitis patient group: (1) Age >=18 years, able to fully understand the study instructions and cooperate in completing all subjective examination items; (2) After fully understanding the purpose, methods, potential benefits and risks of this study, voluntarily participate in the study, and personally sign the written informed consent form, with good compliance and cooperation with follow-up visits; (3) Based on medical history, signs and auxiliary examination results, clinically diagnosed as neurotrophic keratitis with reference to the "Chinese Expert Consensus on the Diagnosis and Treatment of Neurotrophic Keratitis (2021)"; all patients must be clearly diagnosed as "neurotrophic keratitis" by a specialist in the Corneal and Ocular Surface Disease Department of the Eye Hospital of Wenzhou Medical University in the outpatient clinic. (4) Able to tolerate the airflow stimulation and mechanical stimulation during the examination process, i.e., not in the acute phase, and no risk of corneal perforation. (5) If both eyes are affected, a randomization method will be used to determine which single eye is included in the study; if only one eye is affected, only the affected eye will be included in the study, and the contralateral healthy eye will not be included in the healthy group.

排除标准：

1.健康组： (1)合并可能引起周围神经病变影响角膜知觉的全身性疾病，包括但不限于糖尿病、帕金森病、多发性硬化症、自身免疫性疾病等； (2)既往眼部手术史，包括屈光手术史，外伤史，角膜异物或化学酸碱烧伤史； (3)既往长期或近3个月佩戴接触镜史； (4)患有精神心理疾病、认知功能障碍，或存在任何其他无法理解研究指示并无法完成主观检查及随访的情况； (5)妊娠期或哺乳期女性，同期参与其他干预性临床研究等研究者判断存在任何其他不适合参与本研究的因素。 2.神经营养性角膜炎患者组： (1)患有精神心理疾病、认知功能障碍，或存在任何其他无法理解研究指示并无法完成主观检查及随访的情况； (2)妊娠期或哺乳期女性，同期参与其他干预性临床研究等研究者判断存在任何其他不适合参与本研究的因素。

Exclusion criteria：

1. Healthy Group: (1) Have systemic diseases that may cause peripheral neuropathy affecting corneal sensation, including but not limited to diabetes, Parkinson's disease, multiple sclerosis, autoimmune diseases, etc.; (2) History of eye surgery, including refractive surgery, history of trauma, history of corneal foreign bodies or chemical burns; (3) History of long-term or recent (within 3 months) contact lens wear; (4) Suffering from psychiatric disorders, cognitive dysfunction, or any other condition that prevents understanding study instructions and completing subjective examinations and follow-ups; (5) Pregnant or breastfeeding women, simultaneously participating in other interventional clinical studies, or any other factors judged by the researchers to be unsuitable for participating in this study. 2. Patients with Neurotrophic Keratitis: (1) Suffering from psychiatric disorders, cognitive dysfunction, or any other condition that prevents understanding study instructions and completing subjective examinations and follow-ups; (2) Pregnant or breastfeeding women, simultaneously participating in other interventional clinical studies, or any other factors judged by the researchers to be unsuitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-01 00:00:00 至 To 2026-06-01 00:00:00  

干预措施：

Interventions：

组别：

健康组

样本量：

100

Group：

Healthy group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

神经营养性角膜炎患者组

样本量：

30

Group：

NK group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

温州医科大学附属眼视光医院 

单位级别：

三级甲等 

Institution
hospital：

Eye Hospital, Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

眼小医非接触式角膜知觉仪测得角膜知觉阈值（单位：mbar）

指标类型：

主要指标

Outcome：

Corneal sensation threshold measured by the Dr.eye non-contact corneal aesthesiometer

Type：

Primary indicator

测量时间点：

受试者完成基线评估并确认符合入排标准后

测量方法：

检查采用“二分法”联合“极限法”标准化流程测定角膜知觉阈值，以递增序列和递减序列所得结果的算数平均值（T1+T2）/2作为最终阈值（单位：mbar）

Measure time point of outcome：

After the subject completes the baseline assessment and is confirmed to meet the inclusion and exclu

Measure method：

The examination uses a standardized procedure combining the “staircase method” and the “limits method” to determine the corneal sensation threshold. The arithmetic mean of the results obtained from the ascending and descending series, calculated as (T1 + T2)/2, is used as the final threshold.

指标中文名：

Cochet-Bonnet接触式角膜知觉仪测得角膜感知到刺激的最长尼龙丝长度（单位：mm）

指标类型：

主要指标

Outcome：

The longest nylon filament length at which the cornea perceives the stimulus, measured by the Cochet-Bonnet contact corneal aesthesiometer

Type：

Primary indicator

测量时间点：

受试者完成基线评估并确认符合入排标准后

测量方法：

从60 mm尼龙丝开始垂直轻触角膜中央区表面，若受试者无反应则逐步缩短尼龙丝长度，直至受试者报告明确感知。记录能感知到刺激的最长尼龙丝长度（单位：mm）作为接触式角膜知觉阈值。

Measure time point of outcome：

After the subject completes the baseline assessment and is confirmed to meet the inclusion and exclu

Measure method：

Start with a 60 mm nylon filament lightly touching the central corneal surface perpendicularly. If the subject does not respond, gradually shorten the filament length until the subject reports a clear sensation. The longest filament length that elicits a response is recorded as the contact corneal sensation threshold.

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 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）：

由一名不参与后续检查的研究者使用SPSS 28.0专业统计软件生成两个随机序列：眼别随机化序列：以1:1的比例分配至“左眼”或“右眼”，用于确定受试者接受检查的单眼；非接触式检查者顺序随机化序列：以1:1的比例分配至“先A后B”或“先B后A”，用于确定非接触式检查中两名检查者（A、B）的操作顺序

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

A researcher not involved in the subsequent examinations used SPSS 28.0 professional statistical software to generate two randomization sequences: Laterality randomization sequence: allocated to “left eye” or “right eye” at a 1:1 ratio to determine which eye of the subject would undergo the examination; Non?contact examiner order randomization sequence: allocated to “A then B” or “B then A” at a 1:1 ratio to determine the order in which the two examiners (A and B) performed the non?contact measurements.

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：

双盲

Blinding：

Double blind

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）：

研究结束后，原始数据作为发表文章的补充材料刊登

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

After the study, the original data were published as supplementary material to the published article

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：

设计专用的纸质病例报告表及检查结果记录表，用于现场记录受试者的原始数据，表格由检查者在检查过程中即时填写，确保数据记录的及时性和准确性。 本研究采用经过验证的电子数据采集系统建立研究数据库，用于数据的录入、整理和统计分析。所有纸质病例报告表数据由2名研究者独立录入电子数据库，由另一名研究者对两份数据库进行一致性比对。

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

A dedicated paper case report form and examination result recording form will be designed for on-site documentation of the subjects’ raw data. The forms will be completed by the examiner in real time during the examination to ensure timeliness and accuracy of data recording.This study will use a validated electronic data capture system to establish the study database for data entry, organization, and statistical analysis. All data from the paper case report forms will be independently entered into the electronic database by two researchers, and a third researcher will perform consistency checks between the two databases.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-27 18:01:11