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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021628
Receipt No. R000024945
Scientific Title Visual function evaluation of amblyopic patients before and after treatment
Date of disclosure of the study information 2016/03/31
Last modified on 2016/03/27

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Basic information
Public title Visual function evaluation of amblyopic patients before and after treatment
Acronym Visual function of amblyopic patients
Scientific Title Visual function evaluation of amblyopic patients before and after treatment
Scientific Title:Acronym Visual function of amblyopic patients
Region
Japan

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

Objectives
Narrative objectives1 To evaluate visual function of amblyopic patients before and after treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Functional visual acuity
Key secondary outcomes Visual acuity, contrast sensitivity, and higher order aberration

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
0 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria patients with various amblyopia
Key exclusion criteria difficulty in examination
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sujin Hoshi
Organization Faculty of Medicine, University of Tsukuba
Division name Ophthalmology Department
Zip code
Address 1-1-1 Tennoudai, Tsukuba city, Ibaraki, Japan
TEL 029-853-3148
Email hoshisujin@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sujin Hoshi
Organization Faculty of Medicine, University of Tsukuba
Division name Ophthalmology Department
Zip code
Address 1-1-1 Tennoudai, Tsukuba city, Ibaraki, Japan
TEL 029-853-3148
Homepage URL
Email hoshisujin@md.tsukuba.ac.jp

Sponsor
Institute Ophthalmology department, Faculty of Medicine, University of Tsukuba
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information case control study
amblyopic patients who visit University of Tsukuba Hospital
February 2016 to January 2022
Visual acuity, functional visual acuity, contrast sensitivity, higher order aberration will be measured

Management information
Registered date
2016 Year 03 Month 27 Day
Last modified on
2016 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024945

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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