UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055356 |
|---|---|
| Receipt number | R000063261 |
| Scientific Title | Directional preferences for dynamic visual acuity in normal subjects |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2026/03/05 19:37:03 |
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Basic information
Public title
Directional preferences for dynamic visual acuity in normal subjects
Acronym
Examination of directional preferences for dynamic visual acuity
Scientific Title
Directional preferences for dynamic visual acuity in normal subjects
Scientific Title:Acronym
Directional preferences for dynamic visual acuity in normal subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the directional preferences of dynamic visual acuity in healthy subjects by examining the dynamic reaction velocity thresholds in each direction in the central fovea.
Basic objectives2
Others
Basic objectives -Others
Directional preferences of dynamic visual acuity
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation and significant difference of dynamic reaction velocity thresholds in each direction of the dynamic target.
Key secondary outcomes
Correlation and significant difference in eye movement change during confirmation of dynamic target.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects 18 years of age or older who have undergone practical training at the Department of Ophthalmology, Keio University Hospital during the period of this study, who have been fully informed of the purpose and content of the study, who have the capacity to consent, who have voluntarily volunteered to participate in the study upon thorough understanding, and who have agreed to participate in the study in writing
Key exclusion criteria
1. Subjects who have been diagnosed with or are undergoing treatment for dementia or psychiatric disorders
2. Subjects who are unable to undergo accurate examination due to eye disease or other systemic diseases
3. Subjects have a history or suspected or confirmed diagnosis of alcohol or other drug addiction
4. Subjects who are unable to understand the evaluation and the tests/procedures
5. Subjects who, in the judgment of the principal investigator, may be considered incapable of performing the study
6. Subjects who are otherwise deemed unsuitable for the study by the principal investigator, research coordinator, or physician in charge of the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Norimitsu |
| Middle name | |
| Last name | Ban |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
nban@keio.jp
Public contact
Name of contact person
| 1st name | Norimitsu |
| Middle name | |
| Last name | Ban |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
Homepage URL
nban@keio.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 09 | 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
35
Results
Thirty-five subjects participated, with a mean age of 23.71 +- 1.04 years and a mean CDVA of 436.07 +- 119.99 degree/s. Moderate or stronger correlations were observed across all direction combinations, and no significant differences were found in CDVA across the eight directions (p=0.352, Friedman test).
Results date posted
| 2026 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the subjects was 23.71 +- 1.04 years, the mean subjective equivalent spherical power was -3.98 +- 3.12 D, and the mean axial length was 25.76 +- 1.22 mm, indicating that the subjects were primarily young myopes. Mean CDVA was 436.07 +- 119.99 degree/s, and the average examination time was 646.86 +- 224.78 sec. The illuminance in the room used for the experiment was 485.19 +- 34.85 lux.
Participant flow
During the study period, 36 subjects were eligible. One subject was excluded because the computer malfunctioned during the test, making continuation impossible, and he declined retesting. Thus, 35 subjects (male: female = 26:9) were included in the analysis.
Adverse events
None
Outcome measures
The correlation and significant difference of reaction speed threshold for each direction of central dynamic visual acuity, the correlation and significant difference of change in eye movement when checking a moving visual target, and the identification of factors related to central dynamic visual acuity were investigated.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study and subjects who meet the criteria can be enrolled.
Management information
Registered date
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063261
