UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048104 |
|---|---|
| Receipt number | R000054823 |
| Scientific Title | Binocular Occlu-tab vs monocular patching for treatment of amblyopia in Indian children |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2023/06/21 10:21:01 |
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Basic information
Public title
A Study of Occlu-tab for amblyopia treatment in India
Acronym
A Study of Occlu-tab for amblyopia treatment in India
Scientific Title
Binocular Occlu-tab vs monocular patching for treatment of amblyopia in Indian children
Scientific Title:Acronym
Binocular Occlu-tab vs monocular patching for treatment of amblyopia in Indian children
Region
| Asia(except Japan) |
Condition
Condition
amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of the visual function training device Occlu-tab (Class I medical device) in India
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Best-corrected visual acuity(Before treatment and weekly after the start of treatment)
Key secondary outcomes
Binocular visual function(stereopsis)before and after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two months of Amblyopia training using Occlu-tab at hospital.
Occlu-tab training for 3 days a week(1 hour per session) at hospital.
Interventions/Control_2
Two months of Amblyopia training using eye patching training at hospital.
Eye patching training for 3 days a week(1 hour per session) at hospital.
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type of amblyopia: anisometropic amblyopia (Refraction difference of both eyes 2 diopter or more).Visual acuity of the amblyopia eye<=0.1(logMAR).
Key exclusion criteria
Patients were excluded if they had a history of amblyopia treatment, were diagnosed with strabismus, had difficulty in completing the visual acuity or refraction examination, or were receiving occlusion therapy by eye patch.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Hansa |
| Middle name | |
| Last name | Thakkar |
Organization
Civil Hospital Ahmedabad
Division name
M&J Institute of Ophthalmology
Zip code
380016
Address
Ahmedabad, Gujarat, India 380016
TEL
22681010
hansaht@yahoo.co.in
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Ishigaki |
Organization
University of Electro-Communications
Division name
Graduate School of Informatics and Engineering
Zip code
1828585
Address
1-5-1, Chofugaoka, Chofu, Tokyo, Japan
TEL
0424435000
Homepage URL
ishigaki@uec.ac.jp
Sponsor or person
Institute
Japan International Cooporation Agency
Institute
Department
Personal name
Funding Source
Organization
Japan International Cooporation Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional Ethics Committee, B.J. Medical College & Civil Hospital, Ahmedabad
Address
Office of the Medical Superintendent, Civil Hospital, Ahmedabad, India 380016
Tel
7922683721
Not Available
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
| 2022 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 04 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054823
| 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 |
