UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021241 |
|---|---|
| Receipt number | R000024505 |
| Scientific Title | Eye movement for intermittent exotropia |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2021/03/02 09:10:18 |
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Basic information
Public title
Eye movement for intermittent exotropia
Acronym
Eye movement of intermittent exotropia
Scientific Title
Eye movement for intermittent exotropia
Scientific Title:Acronym
Eye movement of intermittent exotropia
Region
| Japan |
Condition
Condition
intermittent exotropia
Classification by specialty
| Ophthalmology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate for eye movement of intermittent exotropia by video oculography during the reading of text.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saccadic disconjugacy in the intermittent exotropia group and taht in the control group during reading
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
A novel sentences were displayed on a liquid crystal monitor placed horizontally.
The subjects read the sentences less than 10 pages. The subject's eye movement is measured using a high-speed video oculography.
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No eye disease without refractive error in the control group.
The patient with intermittent exotropia.
Volunteers who were informed of this study and consented to participate.
Key exclusion criteria
Volunteers who have eye disease without refractive error and intermittent exotropia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujikado |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3941
fujikado@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Hirota |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3943
Homepage URL
hirota@sensory.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of applied visual science, Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of applied visual science, Osaka university graduate school of medicine
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
Osaka university
Address
2-2 yamadaoka, suita osaka
Tel
06-6210-8295
565-0871
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 | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2016 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | 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
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024505
| Research Plan | |
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| 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 |
