UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017596 |
|---|---|
| Receipt number | R000020384 |
| Scientific Title | Retinal imaging (Spectral-domain Optical coherence tomography; SD-OCT) in Parkinson disease |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/05/17 10:16:22 |
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Basic information
Public title
Retinal imaging (Spectral-domain Optical coherence tomography; SD-OCT) in Parkinson disease
Acronym
Retinal imaging in Parkinson disease
Scientific Title
Retinal imaging (Spectral-domain Optical coherence tomography; SD-OCT) in Parkinson disease
Scientific Title:Acronym
Retinal imaging in Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the validity of retinal imaging (Spectral-domain Optical coherence tomography; SD-OCT) in Parkinson disease patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The thinning of inner plexiform layer (IPL) and inner nuclear layer (INL) in the retina of Parkinson disease patients (compared to age matched healthy control)
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Spectral-domain Optical coherence tomography (SD-OCT)
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Idiopathic Parkinson disease (PD) patients who meet the United Kingdom brain bank criteria for idiopathic PD
Key exclusion criteria
(1) Cognitively abnormal PD patients and controls (diagnosed by Mini-Mental State Examinaion (MMSE) score under 20 points)
(2) PD patients and controls with any retinal pathological conditions, which effect on the results of the SD-OCT scan
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushi Takahashi |
Organization
Saitama Medical University
Division name
Department of Neurology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama-ken, Japan
TEL
049-276-1208
tkazushi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazushi Takahashi |
Organization
Saitama Medical University
Division name
Department of Neurology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama-ken, Japan
TEL
049-276-1208
Homepage URL
tkazushi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research-KAKENHI
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
埼玉医科大学病院(埼玉県)，Saitama Medical University Hospital (Saitama-ken)
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
Terminated
Date of protocol fixation
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
