UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029641 |
|---|---|
| Receipt number | R000033858 |
| Scientific Title | Comparison between amblyopia treatment with glasses only and combination of glasses and open-type binocular Occlu-pad device |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2020/04/23 08:33:39 |
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Basic information
Public title
Comparison between amblyopia treatment with glasses only and combination of glasses and open-type binocular Occlu-pad device
Acronym
Amblyopia treatment using Occlu-pad
Scientific Title
Comparison between amblyopia treatment with glasses only and combination of glasses and open-type binocular Occlu-pad device
Scientific Title:Acronym
Amblyopia treatment using Occlu-pad
Region
| Japan |
Condition
Condition
Anisometropic amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate amblyopia treatment by comparing training with glasses only and training with glasses and the Occlu-pad, which is a binocular open-type amblyopia training device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity and binocular visual function at 3 months and 6 months after amblyopia training started
Key secondary outcomes
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
| 3 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with anisometropic amblyopia
Highest visual acuity of amblyopic eyes was 0.1 (LogMAR) or less
Refraction difference of both eyes was 2D or more
Key exclusion criteria
Patients with amblyopia treatment history
Patients with strabismus
Patients in whom it was difficult to perform visual acuity and refraction tests
Patients with astigmatism of 1.50 D or greater
Patients who underwent occlusion therapy using an eye patch
Target sample size
40
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
042-778-9671
iwatayo@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Iwata |
| Middle name | |
| Last name | Yo |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Sagamihara 252-0373, Japan
TEL
042-778-9671
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
| 2017 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
48
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
| 2014 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients were classified into a Glasses treatment group (treated with only glasses) and the Occlu-pad treatment group (treated with glasses in combination with the Occlu-pad).By analyzing visual acuity at 3 months and 6 months after amblyopia training begins, verify the amblyopia training effect of Occlu-pad.
Management information
Registered date
| 2017 | Year | 10 | Month | 20 | Day |
Last modified on
| 2020 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033858
| 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 |
