UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002393 |
|---|---|
| Receipt number | 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 13:41:29 |
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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
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
Sponsor or person
Institute
Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002940
