臨床研究等提出・公開システム

Scientific Title	Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease (Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease)
Public Title	Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease (Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease)

Completion date	Jan. 08, 2020
Result actual enrolment	0
Baseline Characteristics	From the analysis of the data accumulated before the start of this study, it was concluded that the relationship between hallucinations and pupillary abnormalities may not be clear, and the number of subjects was 0.
Participant flow	Although 40 cases were planned for this study, it was concluded from the analysis of the data accumulated before the start of this study that the relationship between visual hallucinations and pupillary abnormalities may not be clear. Therefore, the study was completed with 0 cases.
Adverse events	None
Outcome measures	Not performed.
Brief summary	The possibility that pupillary autonomic dysfunction is associated with the visual hallucination in Parkinson's disease is unclear in this study.
Date of posting of results summaries	Feb. 15, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Not planned
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041180018

Contact for Scientific Queries	Name	katsuno Masahisa
	Affiliation	Nagoya University Graduate School of Medicine
	Address	65 Tsurumai-cho, Showa-ku, Nagoya
	Telephone	+81-52-744-2391
	E-mail	ka2no@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Nakamura Tomohiko
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya
	Telephone	+81-52-744-2604
	E-mail	tomohiko@med.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 01, 2017
Actual date of first enrollment		Sept. 04, 2017
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Parkinson disease and related diseases
	Exclusion Criteria	Pupillary autonomic neuropathy
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Parkinson's disease and related diseases
Intervention(s)		Two drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eye
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Correlation between pupil autonomic function and hallucination
Secondary Outcome(s)		Correlation between pupil autonomic function and cognitive function, and UPDRS

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya University Clinical Research Review Board
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 04, 2019

Secondary ID(s)	UMIN000026128
Issuing Authority	UMIN Clinical Trials Registry

Countries of Recruitment（Except Japan）	None

History of Changes

List of change history