UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008237 |
|---|---|
| Receipt number | R000009709 |
| Scientific Title | Normal values of retinal sensitivity determined by macular integrity assessment |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2012/12/25 08:00:23 |
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Basic information
Public title
Normal values of retinal sensitivity determined by macular integrity assessment
Acronym
Normal values of retinal sensitivity
Scientific Title
Normal values of retinal sensitivity determined by macular integrity assessment
Scientific Title:Acronym
Normal values of retinal sensitivity
Region
| Japan |
Condition
Condition
Negative history for any ocular or systemic diseases.
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the retinal sensitivity of healthy subjects determined by Macular Integrity Assessment (MAIA), and to evaluate the relationship between retinal sensitivity and age in a group of subjects with a wide range of age. We also attempted to determine which factors were associated to retinal sensitivity when examined by MAIA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retinal sensitivity,Visual acuity,Refractive error,Axial rength
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
| 5 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
criteria include a negative history of any ocular disease
Key exclusion criteria
oculae or sysstemic disease such as glaucoma, uveitis, retinal disease, diabetes melitus
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Shiraga |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Ophthalmology
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atushi Fujiwara |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Ophthalmology
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
To investigate the retinal sensitivity of health subjects determined by Macular Integrity Assessment.
Management information
Registered date
| 2012 | Year | 06 | Month | 23 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009709
