UMIN-CTR Clinical Trial

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

Contact us.