UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019326 |
|---|---|
| Receipt number | R000022343 |
| Scientific Title | Functional evaluation of the retinal photoreceptor |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2019/04/16 09:12:41 |
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Basic information
Public title
Functional evaluation of the retinal photoreceptor
Acronym
Functional evaluation of the retinal photoreceptor
Scientific Title
Functional evaluation of the retinal photoreceptor
Scientific Title:Acronym
Functional evaluation of the retinal photoreceptor
Region
| Japan |
Condition
Condition
Retinal degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The retinal degenerations reduce visual acuity because visual acuity has consisted on the high cone density at the fovea. According to World Health Organization, the blindness and low vision ratio in Japan are 0.14% and 0.39% respectively.
The prognosis of retinal degenerations depends on the stage. Therefore, establishing a test method, which detect the retinal degeneration in early stage, expect to reduce the blindness and low vision ratio. Also, that leads to increasing the quality of life in patients with retinal degeneration.
The goal of our study is to establish the new detecting test with the retinal degenerations, which has high detection capability compared with the conventional method, by combining the photobleaching and the adaptive optics scanning laser ophthalmoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
photoreceptor reflectance changes
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
| Other |
Interventions/Control_1
light stimulation of up to 5 minutes
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
No eye disease without refractive error
Volunteers who were informed of this study and consented to participate
Key exclusion criteria
Volunteers who have eye disease without refractive error
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujikado |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3941
fujikado@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kanda |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3943
Homepage URL
kanda@sensory.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of applied visual science, Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of applied visual science, Osaka university graduate school of medicine
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 10 | Month | 13 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022343
