UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003726 |
|---|---|
| Receipt number | R000004509 |
| Scientific Title | Fundus imaging using Swept-source optical coherence tomography (OCT) |
| Date of disclosure of the study information | 2010/06/16 |
| Last modified on | 2013/10/09 10:00:00 |
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Basic information
Public title
Fundus imaging using Swept-source optical coherence tomography (OCT)
Acronym
Fundus imaging using Swept-source optical coherence tomography (OCT)
Scientific Title
Fundus imaging using Swept-source optical coherence tomography (OCT)
Scientific Title:Acronym
Fundus imaging using Swept-source optical coherence tomography (OCT)
Region
| Japan |
Condition
Condition
Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To take images of fundus oculi, and evaluate the equipment based on medical perspective.
To confirm equipment specific performance for healthy volunteers, and then assess fundus images for various cases, and improve the performance.
To develop software applications to extract high-accuracy information.
Basic objectives2
Others
Basic objectives -Others
To examine retinal layered structure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To take retinal OCT images for healthy volunteers and patients by using the OCT equipment, and assess relationship between image quality, such as contrast, and various cases.
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
To examine eligibility and take OCT images 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 or female aged 20 to 80
2) Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease (hypertension, diabetes mellitus)
3) Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria
1) Having any side-effects (hypersensitivity, rised intraocular pressure etc.) against mydriatics
2) Revealed narrow angle by slit-lamp examination
3) Subjects who a doctor in attendance declares ineligible for any reason
Target sample size
400
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
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
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 | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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 | 06 | Month | 08 | 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=R000004509
