UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062792 |
|---|---|
| Receipt number | R000071685 |
| Scientific Title | Assessment of daily visual function using interocular suppression and dynamic stereopsis |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/02 18:30:51 |
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Basic information
Public title
Assessment of daily visual function using interocular suppression and dynamic stereopsis
Acronym
Assessment of daily visual function using interocular suppression and dynamic stereopsis
Scientific Title
Assessment of daily visual function using interocular suppression and dynamic stereopsis
Scientific Title:Acronym
Assessment of daily visual function using interocular suppression and dynamic stereopsis
Region
| Japan |
Condition
Condition
Glaucoma, Macular degeneration, Ritinitis pigmentosa, Amblyopia, Strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare interocular suppression and dynamic stereopsis between individuals with normal visual function and those with ophthalmic diseases, and to evaluate their utility in assessing visual function in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interocular suppression
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
Visual stimulus presentation control
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals diagnosed with any of the following conditions: amblyopia, strabismus, glaucoma, macular degeneration, retinitis pigmentosa.
2. Patients aged 5years or older, including those younger than 18 years and adults, who are able to undergo corrected visual acuity test.
3. Patients with a BCVA(logMAR) of 1.0 or better.
Key exclusion criteria
Individuals who meet any of the following criteria.
1. Individuals with an interocular difference in refractive error of 2.0 diopters or over.
2. Individuals with suspected neuro-ophthalmic abnormalities.
3. Individuals unwilling to participate in the study.
4. Individuals unable to understand the purpose of the study or the procedures involved.
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hayashi |
Organization
Toyama University Hospital
Division name
Department of Ophthalmology
Zip code
930-0194
Address
2630, Sugitani, Toyama-city, Toyama
TEL
076-434-7363
ahayashi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kakeue |
Organization
Toyama University Hospital
Division name
Department of Ophthalmology
Zip code
930-0194
Address
2630, Sugitani, Toyama-city, Toyama
TEL
076-434-2281
Homepage URL
kkakeue@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Universal 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
Clinical and Epidemiological Research Ethics Review Committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama
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 | 07 | 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 | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 02 | 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 | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071685
