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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002393
Receipt No. R000002940
Scientific Title Normative data collection and Software Development for RS-3000
Date of disclosure of the study information 2009/09/01
Last modified on 2010/04/19

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Basic information
Public title Normative data collection and Software Development for RS-3000
Acronym Normative data collection and Software Development for RS-3000
Scientific Title Normative data collection and Software Development for RS-3000
Scientific Title:Acronym Normative data collection and Software Development for RS-3000
Region
Japan Asia(except Japan) Europe

Condition
Condition Healthy individuals
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the clinical study is 3D measurement of retina in the proximity to the optic disc and the macular area with OCT to collect data on normal eyes including thickness of the retina and retinal nerve fiber layer (RNFL) etc. by race, age and sex, which are necessary for macular disease and glaucoma diagnosis.
Basic objectives2 Others
Basic objectives -Others To examine the thickness of retina and retinal nerve fiber layer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To demonstrate the three-dimensional distribution of macular thickness in normal subjects by spectral domain optical coherence tomography (SD-OCT), and to evaluate the association between macular thickness and sex, age, axial length, and race.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Qualifying examination and OCT data acquisition in a day
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Male and female aged 20 and over
2) Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at Clinical center, and can visit on a scheduled examination date
3) Subjects who agree to take the qualifying examination and OCT data acquisition
4) Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria 1) Exclusion criteria regarding systemic disease
a) a) Diabetes mellitus
b) b) Uncontrollable hypertension
c) c) Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
d) d) Cardiac, hepatic, renal and hematologic diseases, and other moderate to severe complications
e) e) During systemic administration of steroid
f) f) History of anticancer agent etc.
g) g) Optically-stimulated epileptic seizure
h) h) Dementia
i) i) Other serious systemic diseases
2) Exclusion criteria regarding ocular disease
a) a) History of keratorefractive surgery
b) b) History of retinal photocoagulation
c) c) History of intraocular surgery
3) Exclusion criteria regarding qualifying examination.
4) Exclusion criteria regarding OCT imaging
Subjects who can or could have any difficulty associated with OCT data acquisition
Target sample size 288

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagahisa Yoshimura
Organization Kyoto University Graduate School of Medicine
Division name Ophthalmology & Visual Sciences
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Ophthalmology & Visual Sciences
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization NIDEK CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya University Graduate School of Medicine
Kanazawa University Graduate School of Medical Science
University of Padova
National University Health System
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
2009 Year 09 Month 01 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
2009 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 27 Day
Last modified on
2010 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002940

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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