UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058852 |
|---|---|
| Receipt number | R000067303 |
| Scientific Title | Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/20 21:22:06 |
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Basic information
Public title
Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks
Acronym
Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks
Scientific Title
Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks
Scientific Title:Acronym
Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks
Region
| Japan |
Condition
Condition
Influence of Visual Factors on Reading Skills: An Analysis Using Reading Tasks
Classification by specialty
| Ophthalmology | Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of reading ability (using MNREAD-Jk and modified charts):
Reading speed
Accuracy
Articulation performance
Comprehension
These outcomes will be integrated as "reading performance" and compared between normal visual conditions and simulated visual impairment conditions (reduced visual acuity and visual field defects).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of reading ability (using MNREAD-Jk and modified charts):
Reading speed
Accuracy
Articulation performance
Comprehension
These outcomes will be integrated as "reading performance" and compared between normal visual conditions and simulated visual impairment conditions (reduced visual acuity and visual field defects).
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Participants (university students with normal vision, aged 18-25 years) will perform reading tasks using the MNREAD-Jk and modified reading charts. They will be asked to read aloud short sentences to assess reading speed, accuracy, articulation performance, and comprehension. Additionally, simulated visual impairment conditions will be introduced, including reduced visual acuity and visual field defects. Reading performance under normal and simulated conditions will then be compared, and the relationship with visual cognitive and articulation abilities will be analyzed.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria:
Students enrolled at Niigata University of Health and Welfare
Aged between 18 and 25 years
Normal visual acuity
Recruitment through the university portal site
No specific exclusion criteria will be applied; all volunteers who provide informed consent will be included
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Institute for the Promotion of Social Collaboration
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
TEL
09030943531
ishii@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Institute for the Promotion of Social Collaboration
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
TEL
0252574533
Homepage URL
ishii@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Masako Ishii
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198, Japan
Tel
0252574455
ishii@nuhw.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
| 2025 | Year | 08 | Month | 20 | 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
| 2025 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067303
