UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037983 |
|---|---|
| Receipt number | R000043296 |
| Scientific Title | Functional and morphological changes of retina and choroid in patients with strabismus and amblyopia |
| Date of disclosure of the study information | 2019/09/11 |
| Last modified on | 2019/09/10 22:39:54 |
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Basic information
Public title
Functional and morphological changes of retina and choroid in patients with strabismus and amblyopia
Acronym
Functional and morphological changes of retina and choroid in patients with strabismus and amblyopia
Scientific Title
Functional and morphological changes of retina and choroid in patients with strabismus and amblyopia
Scientific Title:Acronym
Functional and morphological changes of retina and choroid in patients with strabismus and amblyopia
Region
| Japan |
Condition
Condition
Strabismus and Amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association with visual function and the change of choroid and retina.
Basic objectives2
Others
Basic objectives -Others
morphological change
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association with visual function and morphological changes if choroid and retina
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual sensitivity
Optical coherence tomography
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Strabismus
Amblyopia
Key exclusion criteria
Pretreatment for Strabismus or Amblyopia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumi |
| Middle name | |
| Last name | Gomi |
Organization
Hyogo College Of Medicine
Division name
Department of Ophthalmology
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6111
fgomi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Ookita |
Organization
Hyogo College Of Medicine
Division name
Department of Ophthalmology
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6111
Homepage URL
ookita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College Of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College Of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6111
rinken@hyo-med.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
| 2019 | Year | 09 | Month | 11 | 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
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043296
