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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033637
Receipt No. R000038354
Official scientific title of the study Amblyopia training frequency is more important than training time for improving visual acuity with amblyopia training
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Amblyopia training frequency is more important than training time for improving visual acuity with amblyopia training
Title of the study (Brief title) Amblyopia training frequency and training time
Region
Japan

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

Objectives
Narrative objectives1 How the number of amblyopia training sessions affects the results of amblyopia treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement in visual acuity 3 months after start of amblyopia training
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Amblyopia training with an Occlu-pad twice a week for 30 minutes per training session. Amblyopia training period is 3 months.
Interventions/Control_2 Amblyopia training with an Occlu-pad once a week for 60 minutes per training session. Amblyopia training period is 3 months.
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 Anisometropia amblyopia
Refraction difference of left and right eyes is 2.00 D or more
Amblyopic eye vision is 0.1 or less (LogMAR value)
Key exclusion criteria Patient with strabismus
Patient with oblique position greater than 15 prism
Patients with astigmatism greater than 1.50 D
Patients with a history of amblyopia treatment
Target sample size 38

Research contact person
Name of lead principal investigator 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
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 none
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 08 Month 06 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 01 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 01 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 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038354

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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