UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013237
Receipt No. R000015447
Scientific Title Studies on the clinical usefulness of high-resolution optical coherence tomography in normal subjects
Date of disclosure of the study information 2014/02/24
Last modified on 2014/08/21

* 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 Studies on the clinical usefulness of high-resolution optical coherence tomography in normal subjects
Acronym Clinical usefulness of high-resolution OCT
Scientific Title Studies on the clinical usefulness of high-resolution optical coherence tomography in normal subjects
Scientific Title:Acronym Clinical usefulness of high-resolution OCT
Region
Japan

Condition
Condition Normal subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the scan image of OCT between new system and conventional system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Contrast of high-refractive bands in the outer retina
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 OCT examination
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 subjects
Key exclusion criteria Subjects with eye diseases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, 514-8507, Japan
TEL +81-59-231-5027
Email Mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, 514-8507, Japan
TEL +81-59-231-5027
Homepage URL
Email Mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology (http://www.jsps.go.jp/)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 24 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 Completed
Date of protocol fixation
2014 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2014 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.