UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010684 |
|---|---|
| Receipt number | R000012493 |
| Scientific Title | Skin autofluorescence and its association with ocular diseases involved in oxidative stress |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2014/06/11 15:43:09 |
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Basic information
Public title
Skin autofluorescence and its association with ocular diseases involved in oxidative stress
Acronym
Skin autofluorescence and ocular diseases
Scientific Title
Skin autofluorescence and its association with ocular diseases involved in oxidative stress
Scientific Title:Acronym
Skin autofluorescence and ocular diseases
Region
| Japan |
Condition
Condition
Diabetic retinopathy and macular edema, Hypertensive retinopathy, cataract, glaucoma, age-related macular degeneration, uveitis, optic neuritis, dry eye, chalasis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether skin autofluorescene is associated with severity and prognosis of ocular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of ocular diseases and intensity of skin autofluorescence
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with ocular diseases
Healthy subjects undergoing annual health examinations
Key exclusion criteria
Under 20 years
type 1 diabetes
ongoing hemodialysis
current malignant disease
inflammatory disease
current chronic respiratory disease
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo, Aoba, Sendai, Miyagi, 980-8574, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
| 2013 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
Case-control study.
Skin autofluorescence was correlated to severity of diabetic retinopathy.
Skin autofluorescence was correlated to visual field defect in glaucoma.
Management information
Registered date
| 2013 | Year | 05 | Month | 09 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012493
