UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of complete and incomplete occlusion methods in amblyopia
Acronym	Comparison of occlusive methods for amblyopia
Scientific Title	A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia
Scientific Title:Acronym	Comparison of complete and incomplete occlusion methods in amblyopia
Region	Japan

Condition
Condition	amblyopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	visual acuity improvement period
Key secondary outcomes	Visual acuity refraction value Accommodating paralysis refraction value Eye position Stereoacuity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Continue complete occlusion occlusion treatment until vision is restored to 1.0
Interventions/Control_2	Continue imcomplete occlusion occlusion treatment nis restored to 1.0
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	2 years-old <=
Age-upper limit	9 years-old >
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with functional amblyopia with no eye diseases other than refractive error
Key exclusion criteria	1. Those with eye movement restriction (abduction restriction) 2. Cranial MRI or CT reveals intracranial disease or intraorbital disease 3. Those who have already been diagnosed at another hospital and have already started treatment 4. What the researcher deems inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Totsuka
Organization	Kitasato University hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 Kitasato, Minami-ku, Sagamihara
TEL	0427788111
Email	satoru.totsuka@gmail.com

Public contact
Name of contact person	1st name Satoru Middle name Last name Totsuka
Organization	Kitasato university hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 Kitasato, Minami-ku, Sagamihara
TEL	0427788429
Homepage URL
Email	satoru.totsuka@gmail.com

Sponsor
Institute	Kitasato university hospital
Institute
Department

Funding Source
Organization	Kitasato university hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JPN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato university hospital
Address	1-15-1 Kitasato, Minami-ku, Sagamihara
Tel	0427788111
Email	satoru.totsuka@gmail.com

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 06 Month 03 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	2000 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2024 Year 06 Month 30 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 06 Month 03 Day
Last modified on	2020 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046383

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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