UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029098 |
|---|---|
| Receipt number | R000033211 |
| Scientific Title | Comparison of retinal findings by the wide-angle observation fundus photographing apparatus in the eye disease |
| Date of disclosure of the study information | 2017/09/19 |
| Last modified on | 2017/09/11 22:37:17 |
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Basic information
Public title
Comparison of retinal findings by the wide-angle observation fundus photographing apparatus in the eye disease
Acronym
ultra-wide field fundus photograph findings
Scientific Title
Comparison of retinal findings by the wide-angle observation fundus photographing apparatus in the eye disease
Scientific Title:Acronym
ultra-wide field fundus photograph findings
Region
| Japan |
Condition
Condition
Diabetic retinopathy,Retinal vein occlusion,Uveitis,Glaucoma,age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of retinal findings by ultra-wide-field funds photograph and conventional funds photograph in the eye disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Findings comparison
Compare angle of view
Patient stress
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Fundus imaging using a conventional digital retinal camera and prototype wide fundus photographing device
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those having retinal diseases such as diabetes, retinal vascular occlusive disease, glaucoma, uveitis, age-related macular degeneration, peripheral retinal degeneration
Key exclusion criteria
Minority
Those with a history of epilepsy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Imai |
Organization
Shinshu University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,Nagano
TEL
0263372664
imai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Imai |
Organization
Shinshu University, School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,Nagano
TEL
0263372664
Homepage URL
imai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University, School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | 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
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033211
