UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032198
Receipt number R000036652
Scientific Title Development of new instrument for detecting and treatment of patients with amblyopia
Date of disclosure of the study information 2018/05/06
Last modified on 2018/04/11 12:53:16

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Basic information

Public title

Development of new instrument for detecting and treatment of patients with amblyopia

Acronym

Development of new instrument for detecting and treatment of patients with amblyopia

Scientific Title

Development of new instrument for detecting and treatment of patients with amblyopia

Scientific Title:Acronym

Development of new instrument for detecting and treatment of patients with amblyopia

Region

Japan


Condition

Condition

amblyopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a new instrument for detecting and treatment of patients with ampleopia of much younger age

Basic objectives2

Others

Basic objectives -Others

To develop a new instrument for detecting and treatment of patients with ampleopia of much younger age

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

vision acuity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Examination of eyesight, position of eyes,binocular vision using the special equipment

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

1 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

When, in the patients of children with weak sight or patients with strabismus, the consent form acquisition from a protector is obtained

Key exclusion criteria

patients who disagree to entry this study notified by patients themselves or their guardians. Patients who are judged not suitable for enrolling this study by corresponding medical staff

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kashiwagi

Organization

the University of Yamanashi faculty of medicine

Division name

depertment of opthalmology

Zip code


Address

shimokato 1110,chuo,Yamanashi

TEL

+81552731111

Email

kenjik@yamanashi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Kashiwagi

Organization

University of Yamanashi

Division name

depertment of opthalmology

Zip code


Address

shimokato 1110,chuo,Yamanashi

TEL

0552731111

Homepage URL


Email

kenjik@yamanashi.ac.jp


Sponsor or person

Institute

Department of Ophthalmology,
University of Yamanashi faculty of medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

University Yamanashi department of engineering
University Yamanashi university education center

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

山梨大学医学部


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 06 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

Preinitiation

Date of protocol fixation

2018 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 11 Day

Last modified on

2018 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name