UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005846 |
|---|---|
| Receipt number | R000005249 |
| Scientific Title | Analysis of accommodation disorder by binocular wave-front sensor |
| Date of disclosure of the study information | 2011/06/24 |
| Last modified on | 2011/06/24 16:12:18 |
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Basic information
Public title
Analysis of accommodation disorder by binocular wave-front sensor
Acronym
Analysis of accommodation disorder by binocular wave-front sensor
Scientific Title
Analysis of accommodation disorder by binocular wave-front sensor
Scientific Title:Acronym
Analysis of accommodation disorder by binocular wave-front sensor
Region
| Japan |
Condition
Condition
accommodation disorder
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the characteristic of accommodation disorder from data taken by a binocular wave-front sensor.
Basic objectives2
Others
Basic objectives -Others
To establish new diagnostic method of the accommodation disorder
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time variation of dioptric power.
Time variation of high-order aberration.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Examination by binocular wave-front sensor
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
| 10 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
<Healthy volunteer group>
No eye disease without refractive error
Volunteers who were informed of this study and consented to participate
<Failure of accommodation group>
Patients who were diagnosed with failure of accommodation
Key exclusion criteria
<Healthy volunteer group>
Volunteers who have eye disease without refractive error
<Failure of accommodation group>
Patients who who have eye disease without refractive error or failure of accommodation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujikado |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
Homepage URL
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
Address
Tel
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
| 2011 | Year | 06 | Month | 24 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 24 | Day |
Last modified on
| 2011 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005249
