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跨上皮快速角膜胶原交联术在圆锥角膜治疗中的前瞻性研究
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注册号:

Registration number:

ChiCTR-OIC-16008181 

最近更新日期:

Date of Last Refreshed on:

2016-03-29 

注册时间:

Date of Registration:

2016-03-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

跨上皮快速角膜胶原交联术在圆锥角膜治疗中的前瞻性研究 

Public title:

A prospective study of transepithelial accelerated corneal collagen cross-linking for keratoconus treatment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

跨上皮快速角膜胶原交联术在圆锥角膜治疗中的前瞻性研究 

Scientific title:

A prospective study of transepithelial accelerated corneal collagen cross-linking for keratoconus treatment 

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:

周行涛 

研究负责人:

周行涛 

Applicant:

Xingtao Zhou 

Study leader:

Xingtao Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13671673413 

研究负责人电话:

Study leader's telephone:

+86 13671673413 

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:

doctzhouxingtao@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doctzhouxingtao@163.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:

上海市宝庆路19号 

研究负责人通讯地址:

上海市宝庆路19号 

Applicant address:

19 Baoqing raod, Shanghai  

Study leader's address:

19 Baoqing raod, Shanghai 

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:

复旦大学附属眼耳鼻喉科医院 

Applicant's institution:

Fudan university EENT 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:

ky2012-017-01 

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:

复旦大学附属眼耳鼻喉科医院伦理委员会 

Name of the ethic committee:

the ethical committee of fudan university EENT hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-08-16 

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:

Fudan university EENT hospital 

研究实施负责(组长)单位地址:

上海市宝庆路219号 

Primary sponsor's address:

19 Baoqing raod, 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:

上海市宝庆路219号

Institution
hospital:

Fudan university EENT hospital

Address:

19 Baoqing raod, Shanghai

经费或物资来源:

研究者 

Source(s) of funding:

investigator 

研究疾病:

圆锥角膜 

Target disease:

keratoconus 

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:

IV期临床试验 

Study phase:

研究目的:

研究跨上皮快速角膜胶原交联术在圆锥角膜治疗中的有效性及安全性 

Objectives of Study:

To investigate the safety and efficacy of transepithelial accelerated corneal collagen cross-linking for keratoconus treatment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1,年满18岁,性别种族不限 2,有能力签署知情同意书 3,愿意并遵从试验所有要求,进行所需的随访 4,诊断为圆锥角膜 5,如佩戴隐形眼镜需在筛选器停戴: 隐形眼镜类型 最少停戴时间 软镜 1周 软性持续型佩戴镜片 1周 软性散光镜片 2周 硬性透气性镜片 2周  

Inclusion criteria

1. Be at least 18 years of age, male or female, of any race; 2. Provide written informed consent; 3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 4. Diagnosed as keratoconus; 5. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation TimeSoft 1 WeekSoft Extended Wear 1 WeekSoft Toric 2 Weeks Rigid gas permeable 2 Weeks. 

排除标准:

1,对试验中所用器材及药物禁忌 2,对试验所用器材及药物或其成分已知过敏 3,试验眼全角膜厚度最薄点低于475微米 4,无晶体眼 5,未植入紫外线阻断后房型人工晶体的人工晶体眼 6,植入前房型人工晶体的人工晶体眼 7,受试眼存在除屈光不正以外的其他眼病并可能造成术后并发症,例如 A 除圆锥角膜病外的角膜病史,如病毒性角膜炎,复发性角膜糜烂综合征,角膜溶解,角膜营养不良等 B 研究者判定的将会影响交联过程的明显的角膜瘢痕 C 受试眼有化学伤史或上皮延迟愈合史 8,本试验期内怀孕包括计划怀孕或哺乳期妇女 9,受试者患有眼球震颤或其他疾病,影响手术或其他诊断检查中的固视 10,研究者判定受试者现况可能影响或延长上皮愈合 11,在手术1周内需服用维生素C者 12,接受过角膜基质环植入术或除白内障摘除联合后房型人工晶体植入术的其他经角膜手术者 13,术前3月内接受过白内障摘除术 除此以外还包括研究者判定的任何不适合本研究的医学问题  

Exclusion criteria:

1. Contraindications to the use of the test article(s); 2. A known allergy to the test article(s) or their components; 3. Corneal pachymetry that is <475 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated; 4. Eyes which are aphakic; 5. Eyes which are pseudophakic without the presence of a UV blocking posterior chamberintraocular lens (PCIOL); 6. Eyes which are pseudophakic with an anterior chamber intraocular lens (AC IOL); 7. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: (1) History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.), except keratoconus; (2) Clinically significant corneal scarring in the cross-linking treatment zone that in the investigators opinion, will interfere with the cross-linking procedure; (3) A history of chemical injury or delayed epithelial healing in the eye(s) to be treated; 8. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 9. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests; 10. Patients with a current condition that, in the investigators opinion, would interfere with or prolong epithelial healing; 11. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment; 12. A history of the insertion of Intacs in the eye to be treated or previous corneal surgery other than cataract extraction with PCIOL implantation; 13. A history of cataract extraction occurring within the three months prior to study treatment. Note: In addition, the Investigator may exclude or discontinue any subject for any sound medical reason. 

研究实施时间:

Study execute time:

From2016-04-21To 2018-03-20 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

快速跨上皮角膜胶原交联

干预措施代码:

Intervention:

transepithelial accelerated corneal collagen cross-linking

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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属眼耳鼻喉科医院 

单位级别:

三甲 

Institution
hospital:

Fudan University EENT hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视力

指标类型:

主要指标 

Outcome:

visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

曲率

指标类型:

主要指标 

Outcome:

keratometry

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主觉验光

指标类型:

主要指标 

Outcome:

manifest refraction

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 10 years
最大 Max age 60 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):

非随机

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

non randomize

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

不公开

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

public won't get the access to data

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:

医院专人专柜保管

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

data will be kept in a special cabinet in the hospital and a special person will take charge

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-03-29
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