UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051415 |
|---|---|
| Receipt number | R000058642 |
| Scientific Title | Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2025/06/24 13:45:08 |
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Basic information
Public title
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation
Acronym
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation
Scientific Title
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation
Scientific Title:Acronym
Investigation of the usefulness of a new portable Fresnel magnifying loupe for nystagmus observation
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of the new portable Fresnel magnifying loupe in spontaneous nystagmus observation, we will compare its nystagmus observation ability with conventional Frenzel goggles and the naked eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Slow phase velocity of nystagmus induced by the caloric test during observation with the new loupes, Frenzel goggles, and naked eye.
Key secondary outcomes
Visibility of nystagmus when observed with the new loupes, Frenzel goggles, and naked eye.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Those who understand the content of the research and have given their consent to participate in the research.
Key exclusion criteria
Those who have a history of vertigo.
Those who are considered inappropriate by the principal investigator or investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Ear Institute Clinic
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama, Japan
TEL
+81-48-797-3341
r.tsunoda@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Tsunoda |
Organization
Mejiro University
Division name
Ear Institute Clinic
Zip code
339-8501
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama, Japan
TEL
+81-48-797-3341
Homepage URL
r.tsunoda@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Funding Source
Organization
Mejiro University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Mejiro University
Address
320 Ukiya, Iwatsuki-ku, Saitama-shi, Saitama
Tel
048-797-2115
univsyomu@mejiro.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
目白大学耳科学研究所クリニック(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://doi.org/10.1186/s12245-024-00791-2
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s12245-024-00791-2
Number of participants that the trial has enrolled
15
Results
In observations of nystagmus induced by the caloric test, the visual impact of the loupe was not inferior tothat of Frenzel goggles.
The mean slow-phase velocity of nystagmus recorded with the loupe was significantly higher than that observed with the naked eye.
Nystagmus weakened under bright lighting could be recovered by the loupe as fixation was blocked and the direction of the nystagmus could be defined.
Results date posted
| 2025 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 24 | Day |
Baseline Characteristics
Fifteen healthy participants with no history of visual impairment or dizziness were enrolled.
Participant flow
Written informed consent was obtained from all participants after providing a written explanation of the purpose and methods of the study.
This study was approved by the Medical Research Ethics Committee of Mejiro University (Approval number: 23 medicine-006).
All procedures were performed in accordance with the tenets of the Declaration of Helsinki and its later amendments.
Adverse events
One participant refused second test owing to discomfort from dizziness induced by the caloric test.
The symptoms improved after resting for about 10 minutes.
Outcome measures
VIS of Loupe compared with VIS of Frenzel.
VIS of Loupe (%) = (mean SPV of the loupe) / (mean SPV of complete darkness immediately before) x 100.
VIS of Frenzel (%) = (mean SPV of Frenzel goggles) / (mean SPV of complete darkness immediately before) x 100.
The mean SPV under the naked eye was compared with the mean SPV when using a loupe during the decay phase.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subject recruitment:
The study will be publicized through advertising documents. Written informed consent from the participants will be obtained with explanatory documents.
Methods:
Nystagmus is induced by cold air carolic test.
The slow phase velocity is measured by ENG while observing the nystagmus with a new loupe, Frenzel goggles, and naked eye.
A video of the nystagmus will be simultaneously recorded.
Data Analysis:
Comparison of the slow phase velocities of the three observation methods by Wilcoxon signed rank test.
Evaluation of visibility by video recording.
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058642
