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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033195
Receipt No. R000037850
Official scientific title of the study Comparative study of amblyopia training effect using spectacles and conbination of spectacles and occlu-pad
Date of disclosure of the study information 2018/07/10
Last modified on 2018/06/29

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Basic information
Official scientific title of the study Comparative study of amblyopia training effect using spectacles and conbination of spectacles and occlu-pad
Title of the study (Brief title) Effectiveness verification of Occlu-pad
Region
Japan

Condition
Condition anisometropic amblyopia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparative study of amblyopia training effect using spectacles and conbination of spectacles and occlu-pad
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity after amblyopia treatment and compliance rate of amblyopia training
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Amblyoscopic treatment with Occlu-pad and spectacles
Interventions/Control_2 Amblyoscopic treatment with spectacles
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
3 years-old <=
Age-upper limit
8 years-old >=
Gender Male and Female
Key inclusion criteria refraction difference of both eyes is 2.00 D or more
Amblyopic eye vision is 0.1 (LogMAR value) or less
Key exclusion criteria Patients whose vision test is difficult to enforce
Patient with a history of amblyopia treatment
Patient with strabismus
Patient with astigmatism more than 1.50D
Patient with organic disease affecting vision
Target sample size 46

Research contact person
Name of lead principal investigator Yo Iwta
Organization Kitasato University
Division name School of Allied Health Sciences
Address 1-15-1 Kitasato, Sagamihara 252-0373, Japan
TEL 042-778-9671
Email mm14004q@st.kitasato-u.ac.jp

Public contact
Name of contact person Yo Iwata
Organization Kitasato University
Division name School of Allied Health Sciences
Address 1-15-1 Kitasato, Sagamihara 252-0373, Japan
TEL 042-778-9671
Homepage URL
Email mm14004q@st.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 07 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 29 Day
Anticipated trial start date
2018 Year 07 Month 15 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2018 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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