UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063307 |
|---|---|
| Receipt number | R000072465 |
| Scientific Title | Induction of simulated cyclotropia by wearing a prism-based cyclotropia-correcting lens in young adults without strabismus |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 10:51:11 |
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Basic information
Public title
Verification of visual perception through a prism-based lens for simulating cyclotropia
Acronym
Simulated cyclotropia lens study
Scientific Title
Induction of simulated cyclotropia by wearing a prism-based cyclotropia-correcting lens in young adults without strabismus
Scientific Title:Acronym
Simulated cyclotropia induction lens study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether a simulated cyclotropia can be induced in young adults without strabismus by having them wear a prototype cyclotropia-correcting lens made by combining commercially available prisms, assessed by ocular alignment testing before and while wearing the lens.
Basic objectives2
Others
Basic objectives -Others
To provide basic data on image rotation for the future development of spectacles that correct the visual perception of patients with cyclotropia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in ocular deviation measured by ocular alignment testing before and while wearing the lens
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants wear a prototype cyclotropia-correcting lens made by combining commercially available prisms. Ocular alignment is tested before and while wearing the lens. Total time per participant is less than 5 minutes.
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
Students of Niigata University of Health and Welfare aged 18 to 25 years without strabismus
Individuals who have given written informed consent to participate in this study
Key exclusion criteria
Individuals with ocular diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shunya |
| Middle name | |
| Last name | Tatara |
Organization
Niigata University of Health and Welfare
Division name
Department of Orthoptics and Visual Science, Faculty of Medical Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
TEL
025-257-4752
tatara@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Tatara |
Organization
Niigata University of Health and Welfare
Division name
Department of Orthoptics and Visual Science, Faculty of Medical Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
TEL
025-257-4752
Homepage URL
tatara@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Personal research funds of the principal investigator
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
Tel
025-257-4455
rinri@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
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 16 | 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
There is no plan to share individual participant data.
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072465
