UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011110 |
|---|---|
| Receipt number | R000013011 |
| Scientific Title | Validation of novel inspection method detecting autofluorescence from eye |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/07/21 15:26:06 |
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Basic information
Public title
Validation of novel inspection method detecting autofluorescence from eye
Acronym
Detection of autofluorescence from eye
Scientific Title
Validation of novel inspection method detecting autofluorescence from eye
Scientific Title:Acronym
Detection of autofluorescence from eye
Region
| Japan |
Condition
Condition
cataract with diabetic retinopathy, cataract without diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is validating whether eye autofluorescence correlate with diabetic retinopathy, or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlationship between eye autofluorescence and diabetic retinopathy
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Cataract patients suffered from glaucoma, diabetes without retinopathy, diabetic retinopathy.
-50-69years old
-The patients who consult doctors at Tohoku university hospital
Key exclusion criteria
-The patients suffered from ocular diseases expect for cataract, glaucoma, and diabetic retinopathy
Target sample size
120
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
Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Yasuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
022-717-7294
Homepage URL
myasuda@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
shimadzu
Organization
Division
Category of Funding Organization
Profit 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
東北大学病院 眼科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Autofluorescence from eye and skin is going to be measured.
Management information
Registered date
| 2013 | Year | 07 | Month | 03 | Day |
Last modified on
| 2016 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013011
