UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036112 |
|---|---|
| Receipt number | R000039842 |
| Scientific Title | Fundus shapes with an OCT and myopia |
| Date of disclosure of the study information | 2019/03/06 |
| Last modified on | 2020/03/19 20:13:51 |
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Basic information
Public title
Fundus shapes with an OCT and myopia
Acronym
Fundus shapes and myopia
Scientific Title
Fundus shapes with an OCT and myopia
Scientific Title:Acronym
Fundus shapes and myopia
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Relationship between fundus shape and myopia in consideration of age
Basic objectives2
Others
Basic objectives -Others
High order aberration, corneal shape, relationship with eye axis length are clarified
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Regression of the curvature distribution of the fundus to myopia and its coefficient of determination
Key secondary outcomes
Multiple regression of high order aberration, corneal shape, and axial length to myopia and its coefficient of determination
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy eyes with mild cataract and mild glaucoma
Key exclusion criteria
pathological fundus shape change
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
0298533148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Mihashi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
0298533148
Homepage URL
mihashi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Topcon Coporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Univeristy of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
0298533148
mihashi@md.tsukuba.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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 06 | 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
| 2019 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure both eyes of the subjects using two fundus OCTs, a wavefront sensor, an eye axis measuring device, and an anterior segment OCT.
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039842
