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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024626
Receipt No. R000028320
Scientific Title The attempt of treatment for refractory amblyopia under binocular condition.
Date of disclosure of the study information 2016/10/29
Last modified on 2019/05/08

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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
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
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028320

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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