UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021588 |
|---|---|
| Receipt number | R000023809 |
| Scientific Title | The correlations between miosis in near viewing and age, accommodation amplitude, eye dominance. |
| Date of disclosure of the study information | 2016/03/23 |
| Last modified on | 2017/08/29 15:13:52 |
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Basic information
Public title
The correlations between miosis in near viewing and age, accommodation amplitude, eye dominance.
Acronym
Miosis in near viewing and accommodation amplitude.
Scientific Title
The correlations between miosis in near viewing and age, accommodation amplitude, eye dominance.
Scientific Title:Acronym
Miosis in near viewing and accommodation amplitude.
Region
| Japan |
Condition
Condition
presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the correlations between miosis in near viewing and age, accommodation amplitude, eye dominance.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of pupil diameter between under far viewing and near viewing measured using a binocular open field autorefractometer equipped with a pupilometer.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with the corrected visual acuity of 1.0 and over, and without ocular diseases other than refractive error.
Key exclusion criteria
Subject with corrected visual acuity less than 1.0
Ocular disease other than refractive error
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio university school of medicine
Division name
Department of ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL
81333598302
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio university school of medicine
Division name
Department of ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL
81333598302
Homepage URL
fwic7788@mb.infoweb.ne.jp.
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine
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
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
| 2016 | Year | 03 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
The purpose of this study is to measure the difference of the pupil size between under far viewing and near viewing and reveal its correlations to age, accommodation amplitude and eye dominance.
Study design:cross-sectional study
Recruitment method: Opt-out recruitment to the subjects included in the 'The correlation between outcomes of open-field auto-refractors and age, accommodative power, dominant eye, and outcomes of autor-efractors utilising fixed internal targets'(UMIN000015946)
measurement itsms: age, pupil diameter, accommodative amplitude, eye dominance, refractive data, visual acuity
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023809
