UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011259 |
|---|---|
| Receipt number | R000012685 |
| Scientific Title | A prospective, cross-sectional study of Repeatability and Reproducibility of Retina/ Subfoveal Choroidal Thickness in Normal Eyes Using Different OCT Devices |
| Date of disclosure of the study information | 2013/07/24 |
| Last modified on | 2015/01/23 14:39:52 |
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Basic information
Public title
A prospective, cross-sectional study of Repeatability and Reproducibility of Retina/ Subfoveal Choroidal Thickness in Normal Eyes Using Different OCT Devices
Acronym
Reproducibility of Retina/Choroidal Thickness in Normal Eyes Using Different OCT Devices (A prospective, cross-sectional study)
Scientific Title
A prospective, cross-sectional study of Repeatability and Reproducibility of Retina/ Subfoveal Choroidal Thickness in Normal Eyes Using Different OCT Devices
Scientific Title:Acronym
Reproducibility of Retina/Choroidal Thickness in Normal Eyes Using Different OCT Devices (A prospective, cross-sectional study)
Region
| Japan |
Condition
Condition
Normal eye
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Repeatability and reproducibility of retinal/subfoveal choroidal thickness using three different OCT devices
Basic objectives2
Others
Basic objectives -Others
Repeatability and reproducibility of OCT measurement
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Repeatability and reproducibility of retinal/subfoveal choroidal thickness using three different OCT devices
Key secondary outcomes
Repeatability and reproducibility of Intraclass, interrater and intermachine agreements
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
normal eye
Key exclusion criteria
ocular disease
history of ocular surgery
systemic disease
Highly myopic eyes of -6.0D or more spherical equivalent
Best corrected visual acuity of<20/20
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Matsuo |
Organization
Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
+81-99-275-5402
Homepage URL
myuki@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Medical and Dental Hospital
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
鹿児島大学病院医学部・歯学部付属病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective, cross-sectional study of Repeatability and Reproducibility of Retinal/Subfoveal Choroidal Thickness in Normal Eyes Using Different OCT Devices
Management information
Registered date
| 2013 | Year | 07 | Month | 23 | Day |
Last modified on
| 2015 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012685
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
