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Efficacy of 0.01% low dose atropine for myopia control in Indian population
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注册号:

Registration number:

ChiCTR2100051781 

最近更新日期:

Date of Last Refreshed on:

2021-10-04 

注册时间:

Date of Registration:

2021-10-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Efficacy of 0.01% low dose atropine for myopia control in Indian population 

Public title:

Efficacy of 0.01% low dose atropine for myopia control in Indian population 

注册题目简写:

 

English Acronym:

Efficacy of low dose atropine  

研究课题的正式科学名称:

Efficacy of 0.01% low dose atropine and its correlation with various factors in myopia control in the Indian population 

Scientific title:

Efficacy of 0.01% low dose atropine and its correlation with various factors in myopia control in the Indian population 

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:

Shweta Chaurasia 

研究负责人:

Shweta Chaurasia 

Applicant:

Shweta Chaurasia 

Study leader:

Shweta Chaurasia 

申请注册联系人电话:

Applicant telephone:

+91 99 90909575 

研究负责人电话:

Study leader's telephone:

+91 99 +990909575 

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:

shweta84omns@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

shweta84omns@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:

Advanced Eye Centre, PGIMER, Chandigarh, India 

研究负责人通讯地址:

Advanced Eye Centre, PGIMER, Chandigarh, India 

Applicant address:

Advanced Eye Centre, PGIMER, Chandigarh, India 

Study leader's address:

Advanced Eye Centre, PGIMER, Chandigarh, India 

申请注册联系人邮政编码:

Applicant postcode:

160012 

研究负责人邮政编码:

Study leader's postcode:

160012 

申请人所在单位:

印度医学教育与研究研究生院 

Applicant's institution:

Post Graduate Institute of Medical Education and Research 

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:

NK/4806/MS/033 

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:

PGIMER ethics committee 

Name of the ethic committee:

PGIMER ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-29 

伦理委员会联系人:

Post Graduate Institute of Medical Education and Research 

Contact Name of the ethic committee:

Post Graduate Institute of Medical Education and Research 

伦理委员会联系地址:

Sector 12, Chandigarh, India 

Contact Address of the ethic committee:

Sector 12, Chandigarh, India 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+91 017 22756111 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

iecintpgi@gmail.com 

研究实施负责(组长)单位:

no sponsor; student thesis 

Primary sponsor:

no sponsor; student thesis 

研究实施负责(组长)单位地址:

NA 

Primary sponsor's address:

NA 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

印度

省(直辖市):

Chandigarh

市(区县):

Chandigarh

Country:

India

Province:

Chandigarh

City:

Chandigarh

单位(医院):

Post Graduate Institute of Medical Education and Research

具体地址:

sector 12, Chandigarh

Institution
hospital:

Post Graduate Institute of Medical Education and Research

Address:

sector 12, Chandigarh

经费或物资来源:

None 

Source(s) of funding:

none 

研究疾病:

childhood Myopia 

Target disease:

childhood Myopia 

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:

I期临床试验 

Study phase:

研究目的:

To evaluate the efficacy and safety of low-dose atropine compared to placebo in the Indian population and also to study the impact of various modifiable and non-modifiable factors on myopia progression (MP) and drug efficacy (DE). 

Objectives of Study:

To evaluate the efficacy and safety of low-dose atropine compared to placebo in the Indian population and also to study the impact of various modifiable and non-modifiable factors on myopia progression (MP) and drug efficacy (DE). 

药物成份或治疗方案详述:

It was a single-center prospective placebo-controlled interventional study. 43 participants aged 6-16 years with progressive myopia received 0.01% atropine in the right eyes (treatment) and placebo in the left eyes (control) for 1-year. The main outcome measures were annual MP and axial length elongation (ALE) in treatment and control eyes and their percentage difference between two eyes (DE). Secondary outcome measures were the occurrence of any adverse events and the correlation of MP, ALE, and DE with various factors.  

Description for medicine or protocol of treatment in detail:

It was a single-center prospective placebo-controlled interventional study. 43 participants aged 6-16 years with progressive myopia received 0.01% atropine in the right eyes (treatment) and placebo in the left eyes (control) for 1-year. The main outcome measures were annual MP and axial length elongation (ALE) in treatment and control eyes and their percentage difference between two eyes (DE). Secondary outcome measures were the occurrence of any adverse events and the correlation of MP, ALE, and DE with various factors.  

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

Clinical records of myopic children who underwent cycloplegic refraction at the institution in the past one year were screened and children aged 6-16 years with myopia ranging from -1 D to -7 D (spherical equivalent) in both eyes, progression equal or greater than 0.5 D in the preceding year, stable astigmatism of 1.5 D or less, anisometropia of 2 D or less, and best-corrected visual acuity at least 6/9 were enrolled in the study (selection and enrolment of the children being done until 31st October 2018).  

Inclusion criteria

Clinical records of myopic children who underwent cycloplegic refraction at the institution in the past one year were screened and children aged 6-16 years with myopia ranging from -1 D to -7 D (spherical equivalent) in both eyes, progression equal or greater than 0.5 D in the preceding year, stable astigmatism of 1.5 D or less, anisometropia of 2 D or less, and best-corrected visual acuity at least 6/9 were enrolled in the study (selection and enrolment of the children being done until 31st October 2018).  

排除标准:

Patients with ocular pathology like spherophakia, retinal dystrophies, corneal dystrophy or other diseases, manifest strabismus, allergy to atropine eye drops, or children who were already under treatment for myopia control were excluded.  

Exclusion criteria:

Patients with ocular pathology like spherophakia, retinal dystrophies, corneal dystrophy or other diseases, manifest strabismus, allergy to atropine eye drops, or children who were already under treatment for myopia control were excluded.  

研究实施时间:

Study execute time:

From2019-01-30To 2020-01-31 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2019-12-31 

干预措施:

Interventions:

组别:

Right eyes of children (treatment group) and left eyes of children (control group)of children (treatment group) and left eyes of children (control group)

样本量:

40

Group:

Right eyes of children (treatment group) and left eyes of children (control group)of children (treatment group) and left eyes of children (control group)

Sample size:

干预措施:

low dose atropine versus placebo

干预措施代码:

Intervention:

low dose atropine versus placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

印度 

省(直辖市):

Chandigarh 

市(区县):

Chandigarh 

Country:

India 

Province:

Chandigarh 

City:

Chandigarh 

单位(医院):

PGIME 

单位级别:

三级医院 

Institution
hospital:

PGIMER  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

myopia control

指标类型:

主要指标 

Outcome:

myopia control

Type:

Primary indicator 

测量时间点:

4 monthly

测量方法:

refraction and axial length

Measure time point of outcome:

4 monthly

Measure method:

refraction and axial length

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

NA

组织:

NA

Sample Name:

NA

Tissue:

NA

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 6 years
最大 Max age 16 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):

No

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

No randomisation Right eyes of all children was treatment group and left eyes as control group

盲法:

both the principal investigator and the patient were blinded with the results

Blinding:

both the principal investigator and the patient were blinded with the results

是否共享原始数据:

IPD sharing

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):

N/A

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-04
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