青光眼睫状体炎综合征与原发性开角型青光眼的视野特征比较:一项回顾性横断面研究研究

注册号:

Registration number:

ChiCTR2600122109 

最近更新日期:

Date of Last Refreshed on:

2026-04-09 09:51:37 

注册时间:

Date of Registration:

2026-04-09 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

青光眼睫状体炎综合征与原发性开角型青光眼的视野特征比较:一项回顾性横断面研究研究

Public title:

Comparison of visual field characteristics between glaucomatous ciliary body inflammation syndrome and primary open-angle glaucoma: A retrospective cross-sectional study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

青光眼睫状体炎综合征与原发性开角型青光眼的视野特征比较:一项回顾性横断面研究研究

Scientific title:

Comparison of visual field characteristics between glaucomatous ciliary body inflammation syndrome and primary open-angle glaucoma: A retrospective cross-sectional study

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:

李军花 

研究负责人:

李军花 

Applicant:

Junhua Li 

Study leader:

Junhua Li 

申请注册联系人电话:

Applicant telephone:

+86 571 88185666

研究负责人电话:

Study leader's
telephone:

+86 571 86795918

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:

54064308@qq.com

研究负责人电子邮件:

Study leader's E-mail:

dr.ljh@eye.ac.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:

中国浙江省杭州市上城区凤起东路618号

研究负责人通讯地址:

中国浙江省杭州市上城区凤起东路618号

Applicant address:

No. 618, Fengqi East Road, Shangcheng District, Hangzhou, Zhejiang, China

Study leader's address:

No. 618, Fengqi East Road, Shangcheng District, Hangzhou, Zhejiang, 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:

温州医科大学附属眼视光医院杭州院区

Applicant's institution:

Hangzhou Branch of Wenzhou Medical University Affiliated Eye and Vision Hospital

研究负责人所在单位:

温州医科大学附属眼视光医院杭州院区

Affiliation of the Leader:

Hangzhou Branch of Wenzhou Medical University Affiliated Eye and Vision Hospital

是否获伦理委员会批准:

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(杭)伦审2026研第09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杭州院区伦理委员会

Name of the ethic committee:

Ethic Committee of Eye Hospital at Hangzhou of Wenzhou Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-27 00:00:00

伦理委员会联系人:

陈红霞

Contact Name of the ethic committee:

Chen Hongxia

伦理委员会联系地址:

中国浙江省杭州市上城区凤起东路618号

Contact Address of the ethic committee:

No. 618, Fengqi East Road, Shangcheng District, Hangzhou, Zhejiang, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 571 86726050

伦理委员会联系人邮箱:

Contact email of the ethic committee:

646924356@qq.com

研究实施负责(组长)单位:

温州医科大学附属眼视光医院杭州院区

Primary sponsor:

Hangzhou Branch of Wenzhou Medical University Affiliated Eye and Vision Hospital

研究实施负责(组长)单位地址:

中国浙江省杭州市上城区凤起东路618号

Primary sponsor's address:

No. 618, Fengqi East Road, Shangcheng District, Hangzhou, Zhejiang, 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):

浙江

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:

中国浙江省温州市鹿城区学院西路270号

Institution
hospital:

Eye Hospital, Wenzhou Medical University

Address:

270 Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang, China

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Optional Project (Self-Funded)

研究疾病:

青光眼睫状体炎综合征、原发性开角型青光眼  

Target disease:

Posner-Schlossman syndrome、Primary open-angle glaucoma

研究疾病代码:

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:

本研究通过对比青光眼睫状体炎综合征(PSS)与原发性开角型青光眼(POAG)患者的视野检查结果,分析两组患者的结果差异,归纳PSS患者的视野特点,为临床PSS的诊断提供新的依据,弥补目前临床上PSS的诊断依赖主观症状的局限性。  

Objectives of Study:

This study compared the visual field examination results of patients with Posner-Schlossman syndrome (PSS) and primary open-angle glaucoma (POAG), analyzed the differences in results between the two groups of patients, summarized the visual field characteristics of PSS patients, and provided new evidence for the diagnosis of PSS in clinical practice, filling the current limitation of PSS diagnosis relying on subjective symptoms.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1、视网膜疾病:黄斑病变(如年龄相关性黄斑变性、黄斑裂孔、糖尿病视网膜 病变);视网膜分支/中央动静脉阻塞;视网膜脱离;高度近视眼底病 变;视网膜色素变性;
2、视神经疾病(非青光眼性):缺血性视神经病变;视神经炎;压迫性视神经 病变;视盘玻璃膜疣;
3、严重白内障;
4、角膜白斑/角膜瘢痕;
5、玻璃体积血/严重玻璃体混浊。

Exclusion criteria:

1. Retinal diseases: macular diseases (such as age-related macular degeneration, macular hole, diabetes retinopathy); Retinal branch/central arteriovenous occlusion; Retinal detachment; High myopia fundus lesions; Retinitis pigmentosa;
2. Optic nerve disease (non glaucoma): ischemic optic nerve disease; Optic neuritis; Oppressive optic neuropathy; Optic disc vitreous membrane warts;
3. Severe cataracts;
4. Corneal leukoplakia/corneal scar;
5. Vitreous hemorrhage/severe vitreous opacity.

研究实施时间:

Study execute time:

From 2026-04-17 00:00:00 To 2027-04-17 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-17 00:00:00 To 2026-05-17 00:00:00

干预措施:

Interventions:

组别:

原发性开角型青光眼

样本量:

100

Group:

Primary open-angle glaucoma

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

青光眼睫状体炎综合征

样本量:

100

Group:

Posner-Schlossman syndrome

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

浙江 

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:

视野损害分类

指标类型:

主要指标

Outcome:

Classification of visual impairment

Type:

Primary indicator

测量时间点:

最早一次最为可靠的视野检查

测量方法:

标准自动视野测量(Humphrey Field Analyzer 3;卡尔蔡司医疗)

Measure time point of outcome:

The earliest and most reliable visual field examination

Measure method:

Standard automatic field of view measurement (Humphrey Field Analyzer 3; Carl Zeiss Medical)

指标中文名:

视野指数

指标类型:

次要指标

Outcome:

Visual field index

Type:

Secondary indicator

测量时间点:

最早一次最为可靠的视野检查

测量方法:

标准自动视野测量(Humphrey Field Analyzer 3;卡尔蔡司医疗)

Measure time point of outcome:

The earliest and most reliable visual field examination

Measure method:

Standard automatic field of view measurement (Humphrey Field Analyzer 3; Carl Zeiss Medical)

指标中文名:

平均偏差

指标类型:

次要指标

Outcome:

Mean Deviation

Type:

Secondary indicator

测量时间点:

最早一次最为可靠的视野检查

测量方法:

标准自动视野测量(Humphrey Field Analyzer 3;卡尔蔡司医疗)

Measure time point of outcome:

The earliest and most reliable visual field examination

Measure method:

Standard automatic field of view measurement (Humphrey Field Analyzer 3; Carl Zeiss Medical)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

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 years
最大 Max age 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):

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:

None

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):

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

N

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:

电子采集和管理系统

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

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-04-09 09:51:30