UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040639 |
|---|---|
| Receipt number | R000046383 |
| Scientific Title | A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia |
| Date of disclosure of the study information | 2020/06/03 |
| Last modified on | 2021/06/04 16:57:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
satoru.totsuka@gmail.com
Sponsor or person
Institute
Kitasato university hospital
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2000 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 30 | Day |
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
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.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 |
