UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013698
Receipt number R000015991
Scientific Title Examination of the nearsighted progress depression effect of the low-concentrated atropine in the Japanese primary schoolchild
Date of disclosure of the study information 2014/04/11
Last modified on 2021/04/17 10:01:45

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Basic information

Public title

Examination of the nearsighted progress depression effect of the low-concentrated atropine in the Japanese primary schoolchild

Acronym

Myopia progress prevention instillation trial

Scientific Title

Examination of the nearsighted progress depression effect of the low-concentrated atropine in the Japanese primary schoolchild

Scientific Title:Acronym

Myopia progress prevention instillation trial

Region

Japan


Condition

Condition

myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examin myopia progress depression effect of 0.01% atropine instillation to the myopia of the primary schoolchild, 0.025% cyclopentolate instillation, the raw diet instillation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

refractive error
axial length

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

0.01% atropin instillation

Interventions/Control_2

0.025% cyclopentolate instillation

Interventions/Control_3

Raw diet instillation

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

6 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

There is no eye disease except refractive error

Key exclusion criteria

Contact lens, history of the myopia progress suppression treatment

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Kinoshita

Organization

Kyoto Prefectural University of Medicine

Division name

Ophthalmology

Zip code

602-0841

Address

465, Kajiicho, Kamigyo-ku, Kyoto-City

TEL

075-251-5578

Email

shigeruk@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Hieda

Organization

Kyoto Prefectural University of Medicine

Division name

Ophthalmology

Zip code

602-0841

Address

465, Kajiicho, Kamigyo-ku, Kyoto-City

TEL

075-251-5578

Homepage URL


Email

ohieda@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

465, Kajiicho, Kamigyo-ku, Kyoto-City

Tel

0752515578

Email

ohieda@koto.kpu-m.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 11 Day


Related information

URL releasing protocol

https://jrct.niph.go.jp/re/reports/detail/871

Publication of results

Unpublished


Result

URL related to results and publications

https://jrct.niph.go.jp/re/reports/detail/871

Number of participants that the trial has enrolled

90

Results

There is the entry of approximately 90 people

Under application of the continuation

Results date posted

2020 Year 04 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

90

Participant flow

90

Adverse events

0

Outcome measures

90

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 03 Month 05 Day

Date of IRB

2014 Year 02 Month 19 Day

Anticipated trial start date

2014 Year 03 Month 31 Day

Last follow-up date

2018 Year 08 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 11 Day

Last modified on

2021 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015991


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name