UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021643 |
|---|---|
| Receipt number | R000024958 |
| Scientific Title | Evaluation of ocular circulation using laser speckle. |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2017/04/07 06:00:20 |
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Basic information
Public title
Evaluation of ocular circulation using laser speckle.
Acronym
Ocular circulation using laser speckle.
Scientific Title
Evaluation of ocular circulation using laser speckle.
Scientific Title:Acronym
Ocular circulation using laser speckle.
Region
| Japan |
Condition
Condition
Ocular diseases including retina, choroid, optic nerve and glaucoma.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of ocular circulation with LSFG for ocular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation with visual function of effectiveness of ocular treatment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ocular diseases (retinal, choroidal and optic nerve diseases and glaucoma).
Key exclusion criteria
1)Difficulty for acquire fine images.
2)Difficulty for perform examinations.
Those who cannot receive IC (especially young patients under 20 yrs old).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine.
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University, School of Medicine.
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Mie University, School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Mie University, School of Medicine.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 27 | 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
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Effectiveness for followup
2)Effectiveness for evaluation of treatment
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024958
