UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018906 |
|---|---|
| Receipt number | R000021879 |
| Scientific Title | Statistical study on two picture optotypes visual acuity tests |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/09/04 00:17:37 |
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Basic information
Public title
Statistical study on two picture optotypes visual acuity tests
Acronym
Study of picture optotypes visual acuity tests
Scientific Title
Statistical study on two picture optotypes visual acuity tests
Scientific Title:Acronym
Study of picture optotypes visual acuity tests
Region
| Japan |
Condition
Condition
Amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To statistically study two picture optotypes visual acuity tests which are being used to measure visual acuity in children in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated Snellen visual acuity
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
| 2 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Amblyopia children who can answer visual acuity tests
Key exclusion criteria
people who can not answer visual acuity tests
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tabuchi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
Address
68-1 waku aboshi-ku, Himeji city,Hyogo prefecture, Japan
TEL
810792728555
H.tabuchi@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tabuchi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
Address
68-1 waku aboshi-ku, Himeji city,Hyogo prefecture, Japan
TEL
810792728555
Homepage URL
Eye@tsukazaki-eye.net
Sponsor or person
Institute
Department of Ophthalmology,Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology,Tsukazaki Hospital
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
ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
All participants had their visual acuity tested using both uncorrected visual acuity test and picture optotypes visual acuity
test at the same time. For picture optotypes, we used two figure sets: old figure set and new figure set. The old figure set
consists of 4 figures: fish, butterfly, flower, and bird; the new figure set consists of 4 figures: car, umbrella, apple, and
airplane. For each figure, when the figure was correctly recognized with 50 percent of probability, we statistically
estimated uncorrected visual acuity values using nominal logistic regression. In addition, for each figure set, old and new,
we noted how many figures, out of 4 combinations of figure on each set, were correctly recognized. Then we set the
possible outcomes as 5 integrated index (4/4 correct, 3/4 correct, 2/4 correct, 1/4 correct, and 0/4 correct) and estimated
uncorrected visual acuity value that is considered to be the most appropriate with high sensitivity and specificity based on
the area under the ROC curve (AUC).
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021879
| 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 |
