UMIN-CTR Clinical Trial

Basic information
Public title	The attempt of treatment for refractory amblyopia under binocular condition.
Acronym	The attempt of treatment for refractory amblyopia under binocular condition.
Scientific Title	The attempt of treatment for refractory amblyopia under binocular condition.
Scientific Title:Acronym	The attempt of treatment for refractory amblyopia under binocular condition.
Region	Japan

Condition
Condition	anisometropic amblyopia and microtropic amblyopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to examine the visual acuity and binocular function improvement rate prospectively by binocular based amblyopia treatment with Bangerter filters placed over the non-amblyopic eye, to whom it was difficult to continue the intensive occlusion(eye patch) and/or topical drops of atropine penalization for the fellow eye.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity, binocular function and contrast sensitivity at 2 months after binocular based amblyopia treatment.
Key secondary outcomes	visual acuity, binocular function and contrast sensitivity at 2 month after the treatment end.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Binocular based amblyopia treatment with Bangerter filters placed over the non-amblyopic eye.
Interventions/Control_2
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	10 years-old >=
Gender	Male and Female
Key inclusion criteria	1. The patients who have been diagnosed with anisometropic amblyopia or microtropic amblyopia. 2. The patients who could not continue intensive occlusion therapy and/or topical drops of atropine penalization treatment for the fellow eye. 3. The patients, despite of those treatment more than 6 months with excellent or good compliance, improvement of visual acuity was less than 1 line. 4.The patients who meet the following conditions, 1 and 2, or 1 and 3.
Key exclusion criteria	1. The patients who have ocular disease other than amblyopia and strabismus. 2. The patients with systemic or neurological disease affecting visual function. 3. The patients who are prohibited watching TV or video game for the photo hypersensitive allergy. 4. The patients who were judged to be unsuitable by research doctor. 5. The patients with one of these conditions at least.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Takashi Middle name Last name Furuse
Organization	Kawasaki Medical School General Medical Center
Division name	Department of Ophthalmology
Zip code	700-8505
Address	2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL	0862252111
Email	tfuruse@med.kawasaki-m.ac.jp

Public contact
1st name of contact person	1st name Takashi Middle name Last name Furuse
Organization	Kawasaki Medical School General Medical Center
Division name	Department of Ophthalmology
Zip code	700-8505
Address	2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL	0862252111
Homepage URL
Email	tfuruse@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Kawasaki Medical School Institutional Review Board
Address	577 Matsushima,Kurashikishi-City,Okayama
Tel	+81-86-462-1111
Email	kmsrec@med.kawasaki-m.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	2016 Year 10 Month 29 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	10
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	2016 Year 10 Month 17 Day
Date of IRB	2016 Year 11 Month 22 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2018 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 29 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028320