UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014993 |
|---|---|
| Receipt number | R000009772 |
| Scientific Title | Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO) |
| Date of disclosure of the study information | 2014/08/29 |
| Last modified on | 2014/09/01 17:25:52 |
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Basic information
Public title
Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Acronym
Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Scientific Title
Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Scientific Title:Acronym
Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Region
| Japan |
Condition
Condition
"Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
uveitis,
hereditary retinal dystrophy,
ocular circulation disease,
adult disease"
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"To take images of the human ocular fundus, and evaluate based on medical perspective.
To confirm for clinical condition grasp of a diagnosis of the primary disease and the illness of the primary disease effectively.
To confirm functions in discovery effectively that a ocular complication by the lifestyle related disease and the clinical views that ocular fundus.
"
Basic objectives2
Others
Basic objectives -Others
"To confirm structural change from photoreceptors and a blood vessel morphological feature.
To confirm each characteristic and the difference of healthy volunteers and various cases.
To confirm time-dependent change of healthy volunteers and various cases. "
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To take retinal images for healthy volunteers and patients by using the novel SLO equipment, and assess relationship between fundus images 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 fundus 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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
"Patient
1) Male or female older than 10 years-old
2) patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
uveitis,
hereditary retinal dystrophy,
ocular circulation disease,
adult disease (hypertension, diabetes mellitus)
3) Subjects who sign an informed consent form to participate in the clinical study
In the case of the minority, pro-incarnation agrees.
Healthy volunteers
1) Male or female older than 20 years-old
2) 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
800
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
075-751-3248
nagaeye@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sotaro Ooto |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3248
Homepage URL
ohoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
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
| 2014 | Year | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 18 | 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
| 2014 | Year | 08 | Month | 29 | Day |
Last modified on
| 2014 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009772
