UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023468 |
|---|---|
| Receipt number | 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 09:12:15 |
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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
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
miharu@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
