UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061322 |
|---|---|
| Receipt number | R000070053 |
| Scientific Title | A Study on the Efficacy of Retinal Projection Visual Aids |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/04/20 14:00:29 |
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Basic information
Public title
A Study on the Efficacy of Retinal Projection Visual Aids
Acronym
A Study on the Efficacy of Retinal Projection Visual Aids
Scientific Title
A Study on the Efficacy of Retinal Projection Visual Aids
Scientific Title:Acronym
A Study on the Efficacy of Retinal Projection Visual Aids
Region
| Japan |
Condition
Condition
Low vision among patients currently receiving outpatient care at Tohoku University Hospital
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a retinal-projection visual aid device among individuals with low vision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity using the ETDRS chart.
Key secondary outcomes
Reading acuity, maximum reading speed, and critical print size, measured using MNRead-J; decimal visual acuity; the visual field; medical conditions; possession and grade of disability certificate; type of low-vision aid; assessment of peripheral object recognition; and System Usability Scale score
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Retinal-projection visual aid
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
| 12 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Blindness, according to the WHO (World Health Organization) definition as corrected visual acuity of less than 0.05 in the better eye or a corresponding visual field defect (i.e., a visual field of 10 degrees or less), or low vision, defined as corrected visual acuity of 0.05 or higher but less than 0.3 in the better eye. This includes individuals with visual impairments equivalent to these criteria who experience difficulties in daily life, individuals with visual impairments equivalent to those covered by a visual impairment certificate, and individuals who qualify for receiving low vision care that uses their remaining visual function (excluding care related to the use of Braille). (2) Age 12 to 70 years (at the time of registration). (3) Consent to participate in the study from either the participant or their family.
Key exclusion criteria
(1) Difficulty operating the retinal projection visual aid device; (2) lack of ability to understand the content of examinations or questionnaires; (3) no remaining function in the retina or optic nerve; (4) current use of medications or other treatments designed to enhance retinal sensitivity; (5) history of photosensitivity.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Ophthalmic Precision Medicine Development, United Centers for Advanced Research and Translational Medicine (ART)
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
022-717-7294
satoru.tsuda.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ikumi |
| Middle name | |
| Last name | Takatsu |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
022-717-7294
Homepage URL
ikumi.takatsu.b6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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 | 05 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070053
