UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033609
Receipt number R000038330
Scientific Title Evaluation of objective visual fields using a pupil perimeter in patients with dementia
Date of disclosure of the study information 2018/08/02
Last modified on 2021/01/19 11:24:00

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Basic information

Public title

Evaluation of objective visual fields using a pupil perimeter in patients with dementia

Acronym

New perimeter evaluating pupil fields in dementia

Scientific Title

Evaluation of objective visual fields using a pupil perimeter in patients with dementia

Scientific Title:Acronym

New perimeter evaluating pupil fields in dementia

Region

Japan


Condition

Condition

dementia

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of objective pupil fields using the imo in patients with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The consistencies between results from retinal sensitivity and pupil response.

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

99 years-old >

Gender

Male and Female

Key inclusion criteria

Patients or family members who wished to see an ophthalmological clinic after visiting a dementia clinic.

Key exclusion criteria

Data indicated that the value is impossible to calculate numerically because of patients had unstable fixation or pupil miosis.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Ken
Middle name
Last name Asakawa

Organization

School of Allied Health Science, Kitasato University

Division name

Department of Orthoptics and Visual Science

Zip code

252-0373

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN

TEL

0427789667

Email

asaken@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Asakawa

Organization

School of Allied Health Science, Kitasato University

Division name

Department of Orthoptics and Visual Science

Zip code

252-0373

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN

TEL

0427789667

Homepage URL


Email

asaken@kitasato-u.ac.jp


Sponsor or person

Institute

School of Allied Health Sciences, Kitasato University

Institute

Department

Personal name



Funding Source

Organization

School of Allied Health Sciences, Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitasato University IRB

Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN

Tel

042-778-8273

Email

rinrib@med.kitasato-u.ac.jp


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

2018 Year 08 Month 02 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

14

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

Completed

Date of protocol fixation

2018 Year 05 Month 20 Day

Date of IRB

2018 Year 08 Month 09 Day

Anticipated trial start date

2018 Year 08 Month 03 Day

Last follow-up date

2019 Year 05 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

-Design and Setting: A prospective multicenter clinical study at Kitasato university and Kanagawa Dental University Yokohama Clinic.

-Recruitment: Patients or family members who wished to see an ophthalmological clinic after visiting a dementia clinic of Kanagawa Dental University Yokohama Clinic.


Management information

Registered date

2018 Year 08 Month 02 Day

Last modified on

2021 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name