UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039227 |
|---|---|
| Receipt number | R000044735 |
| Scientific Title | Effects of amblyopia treatment with binocular approach using polarizing film |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/01/22 13:22:30 |
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Basic information
Public title
Effects of amblyopia treatment with binocular approach using polarizing film
Acronym
Amblyopia treatment using polarizing film
Scientific Title
Effects of amblyopia treatment with binocular approach using polarizing film
Scientific Title:Acronym
Amblyopia treatment using polarizing film
Region
| Japan |
Condition
Condition
anisometropic amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of treatment on amblyopia with binocular approach using a polarizing film.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of visual acuity one month after the start of amblyopia treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Amblyopia treatment using polarizing film (one month [2 hours a day])
Interventions/Control_2
Amblyopia treatment using eye patch (one month [2 hours a day])
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 aged 3 to 8 years
Patients with an astigmatism of 2.00 Diopter or more in equivalent spherical power under accommodation paralysis
Patients with a eyesight of 0.1 or less in LogMAR value
Key exclusion criteria
Patients with astigmatism of 1.50Diopter or more
Patients who have more than 15 prism of heterophoria or strabismus
Patients with a history of treatment for amblyopia
Patients who are judged to have difficulty performing the test
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
Allied Health Sciences
Zip code
252-0373
Address
1-15-1, Kitasato, Sagamihara, Kanagawa
TEL
042-778-9671
iwatayo@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Iwata |
Organization
Kitasato University
Division name
Allied Health Sciences
Zip code
252-0373
Address
1-15-1, Kitasato, Sagamihara, Kanagawa
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, Kanagawa
Tel
042-778-9671
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
| 2020 | Year | 02 | Month | 01 | 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
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044735
