UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004377 |
|---|---|
| Receipt number | 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 10:00:51 |
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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
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
Sponsor or person
Institute
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005231
