UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppression of myopia progression by low dose atropine
Title of the study (Brief title)	Suppression of myopia progression by low dose atropine
Region	Japan

Condition
Condition	Childhood Myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study on suppression effect of childhood myopia progression with low dose atropine(0.01%).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Myopia progression at 4 year Cycloplegic subjective refraction Axial length
Key secondary outcomes	Distance best-corrected visual acuity logMAR Near visual acuity was assessed using best corrected distance spectacle correction with a reduced logMAR reading chart Pupil diameter Accommodation amplitude

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.01% atropine Once a day 4 year Single vision lenses
Interventions/Control_2	Single vision lenses
Interventions/Control_3
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	Spherical equivalent -1.50D~-4.50D Astigmatism of less than 1.5D
Key exclusion criteria	A case with ocular disease other than myopia
Target sample size	80

Research contact person
Name of lead principal investigator	Kyoko Ohno-Matsui
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology&Visual Science
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo,Japan113-8519
TEL	03-3813-6111
Email	k.ohno.oph@tmd.ac.jp

Public contact
Name of contact person	Yuki Nishiyama
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology&Visual Science
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo,Japan113-8519
TEL	03-3813-6111
Homepage URL
Email	ynishiyama-tmd@umin.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	M2000-1638
Org. issuing International ID_1	Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科歯科大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 02 Month 12 Day
Anticipated trial start date	2014 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 22 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032904