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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048104
Receipt No. 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 2022/06/20

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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
Email 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
Email ishigaki@uec.ac.jp

Sponsor
Institute Japan International Cooporation Agency
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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