UMIN-CTR Clinical Trial

Public title

Relationship between Digital Phenotypes of Eye Movements and Cognitive Function

Acronym

Eye Movements and Cognitive Function

Scientific Title

Relationship between Digital Phenotypes of Eye Movements and Cognitive Function

Scientific Title:Acronym

Eye Movements and Cognitive Function

Region

Japan

Condition

Dementia, Mild Cognitive Impairment

Classification by specialty

Neurology	Ophthalmology	Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examining the relationship between eye movements and cognitive function

Basic objectives2

Others

Basic objectives -Others

Exploratory study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

eye movement

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Eye movement measurement using a head-mounted display

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

Age-lower limit

50

years-old

<=

Age-upper limit

89

years-old

>=

Gender

Male and Female

Key inclusion criteria

<Dementia / MCI>
1) Inpatients and outpatients of the Department of Neurology and Neuropsychiatry of Kyoto University with suspected cognitive dysfunction.
2) Patients diagnosed by a neurologist or psychiatrist as MCI or mild dementia range (equivalent to FAST classification 2 to 4) based on DSM-5 diagnostic criteria (2013)
3) Age between 50 and 89 years old, regardless of gender.
4) The research subject's visual acuity and mental status must not interfere with neuropsychological testing.
5) The subject's visual acuity and mental status do not interfere with neuropsychological testing.

<normal subjects>
1) Post cataract surgery patients visiting the Department of Ophthalmology, Kyoto University, and inpatients and outpatients of the Department of Neurology, Kyoto University, who are not suspected of cognitive dysfunction in the judgment of the physician in charge.
2) Patients must be between 50 and 89 years of age, regardless of gender.
3) Patients must not have been diagnosed with memory impairment by themselves or their informants (family members or close acquaintances) in the past or present, and their cognitive function and general activities of daily living must be confirmed by the questionnaire.
4) MMSE-J score of 28 points or higher.
5) The patient has not been to a hospital or clinic for psychiatric symptoms (depression, delusions, hallucinations, etc.)

Key exclusion criteria

<Dementia / MCI>
(1) Patients with cognitive impairment of moderate level or higher (FAST classification 5 or higher) who are unable to follow the instructions for ophthalmologic examination
2) Those with obvious abnormalities in visual function
3) suspected claustrophobia.

<Normal subjects>
1) Those with obvious abnormality in visual function
2) Suspected claustrophobia

Target sample size

520

Name of lead principal investigator

1st name	Masahiro
Middle name	Miyake
Last name	Miyake

Organization

Kyoto University

Division name

Department of Ophthalmology and Visual Sciences

Zip code

606-8507

Address

54, Shogoin-kawaharacho, Sakyoku, Kyoto

TEL

0757513248

Email

miyakem@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Masahiro
Middle name
Last name	Miyake

Organization

Kyoto University

Division name

Department of Ophthalmology and Visual Sciences

Zip code

606-8507

Address

54, Shogoin-kawaharacho, Sakyoku, Kyoto

TEL

0757513248

Homepage URL

Email

miyakem@kuhp.kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54, Shogoin-kawaharacho, Sakyoku, Kyoto

Tel

0757534680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

11

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2021

Year

10

Month

18

Day

Date of IRB

2021

Year

10

Month

18

Day

Anticipated trial start date

2021

Year

11

Month

18

Day

Last follow-up date

2026

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

progressing

Registered date

2021

Year

11

Month

12

Day

Last modified on

2023

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052572