中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100041980
最近更新日期： Date of Last Refreshed on：	2021-03-29 13:21:53
注册时间： Date of Registration：	2021-01-10 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	高晓雅医师：请于伦理委员会批准后才开始征募参试者，并与我们联系上传伦理批件。扫频源OCT血管成像在视网膜脉络膜疾病中的应用
Public title：	Application of sweep source OCT angiography in choroidal retinal diseases
注册题目简写：
English Acronym：
研究课题的正式科学名称：	扫频源OCT血管成像在视网膜脉络膜疾病中的应用
Scientific title：	Application of sweep source OCT angiography in choroidal retinal diseases
研究课题代号(代码)： Study subject ID：	SYA202009
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：	高晓雅	研究负责人：	王敏
Applicant：	Xiaoya Gao	Study leader：	Min Wang
申请注册联系人电话： Applicant telephone：	+86 13993680713	研究负责人电话： Study leader's telephone：	+86 13816630287
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：	621004713@qq.com	研究负责人电子邮件： Study leader's E-mail：	wangmin83@yahoo.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：	上海市徐汇区汾阳路83号	研究负责人通讯地址：	上海市徐汇区汾阳路83号
Applicant address：	83 Fenyang Road, Xuhui District, Shanghai	Study leader's address：	83 Fenyang Road, Xuhui District, Shanghai
申请注册联系人邮政编码： Applicant postcode：	200031	研究负责人邮政编码： Study leader's postcode：	200031
申请人所在单位：	复旦大学附属眼耳鼻喉科医院
Applicant's institution：	Eye & ENT Hospital, Fudan University
研究负责人所在单位：	复旦大学附属眼耳鼻喉科医院
Affiliation of the Leader：	Eye & ENT Hospital, Fudan University

是否获伦理委员会批准：	否
Approved by ethic committee：	No
伦理委员会批件文号： Approved No. of ethic committee：		伦理委员会批件附件： Approved file of Ethical Committee：
批准本研究的伦理委员会名称：
Name of the ethic committee：
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

复旦大学附属眼耳鼻喉科医院

Primary sponsor：

Eye & ENT Hospital, Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区汾阳路83号

Primary sponsor's address：

83 Fenyang Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属眼耳鼻喉科医院	具体地址：	徐汇区汾阳路83号
Institution hospital：	Eye & ENT Hospital, Fudan University	Address：	83 Fenyang Road, Xuhui District

经费或物资来源：

医院专项经费

Source(s) of funding：

Special Funds from Eye & ENT Hospital, Fudan University

研究疾病：

湿性年龄相关性黄斑变性、息肉状脉络膜血管病变、中心性浆液性脉络膜视网膜病变、脉络膜血管瘤

Target disease：

wAMD, CSC, PCV, CCH

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：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

利用扫频光源OCTA这一最新技术观察和评价湿性年龄相关性黄斑变性（AMD）、息肉状脉络膜血管病变（PCV）、中心性浆液性脉络膜视网膜病变（CSC）、脉络膜血管瘤等疾病的OCTA改变，探讨上述疾病血流改变和结构改变的相关性，特别是脉络膜的血流成像，并将扫频光源OCTA与传统OCTA的扫描结果进行对比，以明确其在脉络膜血管病变中的成像优势。

Objectives of Study：

Using the latest technology sweep source OCTA to observe and evaluate changes of wet age-related macular degeneration (AMD) polypoidal choroidal vasculopathy (PCV), central serous retinopathy (CSC) choroid hemangioma, investigate the correlation between blood flow changes and structural changes in these diseases,especially the choroid blood flow imaging.To clarify its imaging advantage in choroidal vascular disease.

药物成份或治疗方案详述：

所有被纳入研究的志愿者以及患者在签署知情同意后，均需接受详尽的临床眼科检查，包括采用国际标准视力表以及主觉验光检查其BCVA，裂隙灯下进行眼前节检查，散瞳后用直接检眼镜或裂隙灯下前置镜观察黄斑区，后极部以及视乳头的情况，此外还需在散瞳下行多模式影像学检查。正常人志愿者需进行验光仪及BCVA检查，并留存眼底照相后进行OCT以及SS-OCTA扫描；所有患者除正常志愿者的检查外还需在入组时行FFA和（或）ICGA检查（根据诊断需要进行选择），并在接受治疗后复查BCVA，OCT，SS-OCTA。视患者病情而定是否复查FFA和（或）ICGA。

Description for medicine or protocol of treatment in detail：

All included in the study of volunteers and patients after the signing of the informed consent, all needs to accept the detailed clinical ophthalmology examination, including the adoption of international standards chart and main optometry its BCVA, front section under slit lamp examination, mydriatic or slit lamp with direct ophthalmoscope after front mirror observation in the macular area, department, and according to the condition of the nipple, and also need in mydriatic downward multimodal imaging examination.Normal volunteers were examined by optometry and BCVA, and OCT and SS-OCTA scanning were performed after taking fundus photos.In addition to regular volunteer examinations, all patients should be examined by FFA and/or ICGA (selected according to diagnostic needs) at the time of enrolment and reexamined by BCVA, OCT and SS-OCTA after treatment.Refer to FFA and/or ICGA depending on the patient's condition.

纳入标准：

Inclusion criteria

Normal population:
1.The best corrected visual acuity of both eyes is 1.0, the spherical lens degree is not greater than 4.00, or not less than -6.00;
2.Comprehensive vitreoretinal examination by an experienced ophthalmologist showed no obvious abnormality;
3.No systemic vascular diseases such as hypertension or diabetes;
4.Sign the informed consent
wAMD:
1.Patient was 50 years old;
2.patients had different degrees of pigment epithelial lesions in the fundus.
3.Fluorescent angiography showed obvious CNV lesions with fundus leakage.
4.Patients with new onset of AMD who have not previously received surgery or intraocular injection of PDT or anti-VEGF drugs
PCV:
1.Within 5-6 minutes after ICGA imaging, the patient showed single or multiple nodular polyps or grape-like hyperfluorescence lesions, with or without related abnormal branching choroidal vascular hyperplasia;
2.Patients with primary PCV and no previous operation or intraocular injection of PDT or anti-VEGF drugs;
3.Sign informed consent and be willing to carry out relevant ophthalmic examination and use their data for research.
CSC:
1.Patients with acute mesoplasma can see translucent vesicular swelling under funduscopy, and typical ink stain leakage can be seen by FFA examination;
2.Patients with primary CSC who have not previously received surgery or intraocular injection of PDT or anti-VEGF drugs;
3.Sign informed consent and be willing to carry out relevant ophthalmic examination and use their data for research.
CCH:
1.The lesions of subretinal eminence can be seen under funduscopic view, with or without local omental eminence. Strong tumor fluorescence can be seen in ICGA at early stage, and clear blood vessels can be seen in the tumor, followed by rapid decrease of fluorescence.
2.Patients with primary CCH and no previous operation or intraocular injection of PDT or anti-VEGF drugs.
3.Sign informed consent and be willing to carry out relevant ophthalmic examination and use their data for research.

排除标准：

1由经验丰富的医生进行仔细的裂隙灯以及直接检眼镜检查，排除严重影响屈光间质透明度的疾病，如角膜光学区瘢痕、重度白内障以及严重的玻璃体混浊等，2排除眼部外伤史和眼部手术史（角膜屈光手术除外）
3需排除青光眼、视网膜静脉阻塞、高血压性视网膜病变、糖尿病性视网膜病变等其他眼底疾病。
4患眼的BCVA不小于0.05，球镜度数不大于4.00，或者不小于-6.00。眼底有大量视网膜下出血、积液或者大量玻璃体积血而影响成像的患者被排除。
5患者需能够配合完成相关检查，如无法配合则被排除。
6 OCTA图像不合格的患者被排除。OCTA的成像质量由至少两位眼科医生共同评价，评价内容包括图像清晰度以及信号强度，如不符合要求则重做一次，两次重做后如结果仍不符合要求，则被判定为图像质量不及格。
7未签署知情同意，拒绝将检查结果用于研究的患者。

Exclusion criteria：

1. Careful slit lamp and direct ophthalmoscopic examination by experienced doctors were performed to exclude diseases that seriously affect the transparency of the refractive interstitium, such as corneal optical scar, severe cataract and severe vitreous opacity, etc.
2. A history of eye trauma and eye surgery (except corneal refractive surgery) were excluded.
3. Glaucoma, retinal vein occlusion, hypertensive retinopathy, diabetic retinopathy and other fundus diseases should be excluded.
4. The BCVA of the affected eye is not less than 0.05, the spherical degree is not more than 4.00, or not less than -6.00.Patients with significant subretinal bleeding, fluid effusion, or vitreous hemorrhage that interfered with imaging were excluded.
5. Patients should be able to cooperate to complete the relevant examination, if not, they will be excluded.
6. Patients with unqualified OCTA images were excluded.The image quality of OCTA is evaluated by at least two ophthalmologists, including image sharpness and signal strength. If the image does not meet the requirements, it will be redone once. If the results still do not meet the requirements after two redoes, the image quality will be judged as failing.
7. Patients who did not sign informed consent and refused to use test results for research purposes.

研究实施时间：

Study execute time：

从 From 2020-12-01 00:00:00至 To 2021-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-01-11 00:00:00 至 To 2022-06-01 00:00:00

干预措施：

Interventions：

组别：	渗出性年龄相关性黄斑病变组, 息肉样脉络膜视网膜病变组, 中心性浆液性脉络膜视网膜病变组, 孤立性脉络膜血管瘤组及正常组	样本量：	170
Group：	AMD group, PCV group, CSC group, CCH group and normal group	Sample size：	170
干预措施：	无	干预措施代码：
Intervention：	Nil	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：	徐汇区
Country：	China	Province：	Shanghai	City：	Xuhui District
单位(医院)：	复旦大学附属眼耳鼻喉科医院	单位级别：	三级甲等
Institution hospital：	Eye & ENT Hospital, Fudan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	脉络膜各层血管直径以及脉络膜厚度	指标类型：	主要指标
Outcome：	diameter of choroidal vessels and choroidal thickness	Type：	Primary 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：

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	70	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）：

不适用

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

N/A

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：	N/A
Blinding：	N/A

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）：	2023年请说明共享原始数据的方式
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	June 2023
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：	专用存储设备请阅读网页注册指南中关于数据收集和管理系统的内容。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Dedicated storage equipment
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2021-01-10 16:10:02