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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004377
Receipt No. R000005231
Scientific Title Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000
Date of disclosure of the study information 2010/11/01
Last modified on 2013/10/09

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Basic information
Public title Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000
Acronym Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000
Scientific Title Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000
Scientific Title:Acronym Data collection in Non-diseased Eyes with Long Axial Length and Development of Software using RS-3000
Region
Japan Asia(except Japan)

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

Objectives
Narrative objectives1 The aim of this clinical study is to develop a software, together with the client of the clinical study, that helps in making diagnoses of macular diseases and glaucoma. The software will be based on the database that contains retinal thickness of healthy subjects, by age, sex and AL, obtained by RS-3000 images.
Basic objectives2 Others
Basic objectives -Others 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 Non-diseased Eyes with Long Axial Length 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
5) Axial length is 26mm or more but less than 30mm.
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)Life-threatening and Debilitating disease
j) j)Subjects who currently (within the past 14 days) take any medication which stimulates photosensitivity (e.g. Visudyne, Ciprofroxacin, Bactrim or doxycycline), and subjects who administer concomitant hydroxychloroquine and chloroquine
k) k) Other serious systemic diseases
2) Exclusion criteria regarding ocular disease
a) a) History of keratorefractive surgery
b) b) History of retinal photocoagulation
c) History of intraocular surgeries except cataract surgery that had been operated before 6 months or more of qualifying examination day
d) Diabetic retinopathy or any other fundus diseases
e) Congenital abnormalities of fundus including optic disc.
f) Any corneal disorders that would prevent the applanation tonometry
g) Serious external ocular diseases, intraocular or eyelid inflammation or external ocular injuries
h) Pathological or degenerative myopia
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
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
TEL
Homepage URL
Email

Sponsor
Institute 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 Japan

Other related organizations
Co-sponsor Nagoya University Graduate School of Medicine, Kanazawa University Graduate School of Medical Science, Tokyo Medical and Dental University, 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
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 No longer recruiting
Date of protocol fixation
2010 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 12 Day
Last modified on
2013 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005231

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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