UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033195 |
|---|---|
| Receipt number | R000037850 |
| Scientific Title | 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 | 2020/06/30 09:07:31 |
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Basic information
Public title
Comparative study of amblyopia training effect using spectacles and conbination of spectacles and occlu-pad
Acronym
Effectiveness verification of Occlu-pad
Scientific Title
Comparative study of amblyopia training effect using spectacles and conbination of spectacles and occlu-pad
Scientific Title:Acronym
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
| 1st name | Yo |
| Middle name | |
| Last name | Iwata |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Sagamihara 252-0373, Japan
TEL
0427789671
iwatayo@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Iwata |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Sagamihara 252-0373, Japan
TEL
0427789671
Homepage URL
iwatayo@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Sagamihara 252-0373, Japan
Tel
0427789671
iwatayo@kitasato-u.ac.jp
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 |
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037850
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
