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
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
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
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
