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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011259
Receipt No. 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

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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
Email 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
Email myuki@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Medical and Dental Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012685

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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