UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024626 |
|---|---|
| Receipt number | 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 14:17:49 |
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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
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
tfuruse@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028320
