UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retinal imaging (Spectral-domain Optical coherence tomography; SD-OCT) in Parkinson disease
Title of the study (Brief title)	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	Kazushi Takahashi
Organization	Saitama Medical University
Division name	Department of Neurology
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama-ken, Japan
TEL	049-276-1208
Email	tkazushi@saitama-med.ac.jp

Public contact
Name of contact person	Kazushi Takahashi
Organization	Saitama Medical University
Division name	Department of Neurology
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama-ken, Japan
TEL	049-276-1208
Homepage URL
Email	tkazushi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020384