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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023468
Receipt No. R000027028
Scientific Title A novel analysis of eye movement by using an eye tracking system
Date of disclosure of the study information 2016/08/04
Last modified on 2021/02/05

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Basic information
Public title A novel analysis of eye movement by using an eye tracking system
Acronym A novel analysis of eye movement by using an eye tracking system
Scientific Title A novel analysis of eye movement by using an eye tracking system
Scientific Title:Acronym A novel analysis of eye movement by using an eye tracking system
Region
Japan

Condition
Condition Ocular motility disturbance
Strabismus
Classification by specialty
Ophthalmology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will clarify the characteristics of eye movement and visual fixation for patients with strabismus, eye movement disorders: paralytic strabismus, myasthenia gravis, graves' disease, by using an eye tracking device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual fixation stability
Velocity of saccadic eye movements
Conjugacy and accuracy of smooth pursuit
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of eye movement by an eye tracking device
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Normal healthy subjects without diplopia, ocular motility disturbance and strabismus
2. Patients with diplopia, ocular motility disturbance and strabismus
Key exclusion criteria We excluded patients who

1. have the lack of cooperation with examination
2. have dyscoria
3. cannot clearly watch the target with the naked eye
4. have the lack of understanding this examination
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Hayashi
Organization University of Toyama
Division name Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code 930-0194
Address 2630 Sugitani, Toyama, Toyama
TEL 076-434-7363
Email ahayashi@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Miharu
Middle name
Last name Mihara
Organization University of Toyama
Division name Department of Ophthalmology Graduate School of Medicine and Pharmaceutical Sciences
Zip code 9390194
Address 2630 Sugitani, Toyama, Toyama
TEL 076-434-7363
Homepage URL
Email miharu@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of University of Toyama
Address 2630 Sugitani, Toyama, Toyama
Tel 076-434-7681
Email rinri@adm.u-toyama.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
2016 Year 08 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 05 Month 26 Day
Date of IRB
2016 Year 05 Month 26 Day
Anticipated trial start date
2016 Year 05 Month 26 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 03 Day
Last modified on
2021 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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