UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062767 |
|---|---|
| Receipt number | R000071839 |
| Scientific Title | An Exploratory Study of the Effects of Interocular Suppression and System Characteristics in Monocular Visual Acuity Testing Under Binocular Viewing Using an Autostereoscopic Display |
| Date of disclosure of the study information | 2026/09/05 |
| Last modified on | 2026/09/01 17:10:40 |
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Basic information
Public title
A comparative study of monocular visual acuity testing performed with both eyes open versus the conventional method
Acronym
A study of monocular visual acuity testing conducted with both eyes open
Scientific Title
An Exploratory Study of the Effects of Interocular Suppression and System Characteristics in Monocular Visual Acuity Testing Under Binocular Viewing Using an Autostereoscopic Display
Scientific Title:Acronym
A Study on a Monocular Visual Acuity Testing Method Under Binocular Viewing
Region
| Japan |
Condition
Condition
Refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the characteristics of a method for presenting a target to only one eye while both eyes remain open in healthy adults, and examines the difference between this method and conventional monocular visual acuity measurement performed with the other eye occluded.
Basic objectives2
Others
Basic objectives -Others
Descriptive characterization of system properties and measurement differences (not intended to demonstrate efficacy or safety)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference between corrected visual acuity (logMAR) measured by the conventional method (one eye occluded) and corrected monocular visual acuity (logMAR) measured using the system with both eyes open
Key secondary outcomes
Technical characteristics of the system, and the effects of measurement conditions on measurement accuracy
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
| Device,equipment |
Interventions/Control_1
Within a single session, monocular visual acuity is measured for the study eye under five visual conditions (including a baseline condition), using both the conventional method (with the other eye occluded) and a new method (presenting the target to only one eye while both eyes remain open). Each measurement takes approximately several tens of seconds, with an interval of several tens of seconds between measurements. The intervention consists of a single session on a single day.
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
Individuals aged 18 years or older at the time of consent, with corrected visual acuity of 1.0 (logMAR 0.0) or better in both eyes on prior standard testing, who are able to understand the study and provide free and voluntary written informed consent.
Key exclusion criteria
Individuals who do not meet the inclusion criteria above, or whom the attending physician or principal investigator judges unsuitable for participation on medical grounds.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hayashi |
Organization
University of Toyama
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
076-434-7363
ahayashi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Oiwake |
Organization
University of Toyama
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
076-434-7363
Homepage URL
toiwake@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Committee for Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.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
| 2026 | Year | 09 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071839
