UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053272 |
|---|---|
| Receipt number | R000060807 |
| Scientific Title | The Adaptation in Near Response Due to Artificially-Induced Aniseikonia |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/11/14 22:41:25 |
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Basic information
Public title
The Adaptation in Near Response Due to Artificially-Induced Aniseikonia
Acronym
The Adaptation in Near Response Due to Artificially-Induced Aniseikonia
Scientific Title
The Adaptation in Near Response Due to Artificially-Induced Aniseikonia
Scientific Title:Acronym
The Adaptation in Near Response Due to Artificially-Induced Aniseikonia
Region
| Japan |
Condition
Condition
Aniseikonia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects and adaptive changes in the near response due to artificially-induced aniseikonia, as well as to capture the aftereffects
Basic objectives2
Others
Basic objectives -Others
The purpose is to deepen the understanding of the visual mechanism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
convergence
accommodation(accommodative response,lag of accommodation)
pupil size
Key secondary outcomes
visual fatigue
stereopeis
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
| Other |
Interventions/Control_1
Participants are required to wear size lenses that alter the image size by 5% for approximately one hour
The procedure is conducted in a single session
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
Male and female individuals aged 18 years and over but under 25 at the time of consent acquisition
Select non-presbyopic participants
Key exclusion criteria
Individuals with ophthalmological disorders other than myopia
Individuals with less than 60 seconds of stereopsis as measured by the Titmus Stereo Test
Individuals who do not possess decimal visual acuity (1.0) or greater
Subjects with an interocular difference in spherical refractive error of more than 2.5 diopters as determined by objective refraction
Individuals with astigmatism greater than 2.0 diopters
Those with an aniseikonia of 1% or more as measured by the New Aniseikonia Test
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Hara |
Organization
International University of Health and Welfare
Division name
School of Health Sciences Department of Orthoptics and Visual Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara City, Tochigi Prefecture
TEL
0287-24-3642
nhara@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | XIAO |
| Middle name | |
| Last name | YANG |
Organization
International University of Health and Welfare
Division name
School of Health Sciences Department of Orthoptics and Visual Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara City, Tochigi Prefecture
TEL
0287-24-3642
Homepage URL
23s1183@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Hara Naoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Regional Ethics Review Committee
Address
Ethics Review Committee Office, 2600-1 Kita-Kanamaru, Otawara City, Tochigi Prefecture
Tel
0287-24-3125
s-rinri@iuhw.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 | 04 | Month | 01 | 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
31
Results
The accommodation decreased after introducing the size lens, reaching a peak at 20 minutes.
The accommodative lag increased right after stimulation but gradually decreased until 20 minutes of adaptation, then returned to baseline.
For pupil size, there was a tendency to increase for both near and far responses immediately after wearing the size lens, returning to baseline after removal.
No changes in convergence were observed for either near or far responses.
Results date posted
| 2024 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were initially 31 participants (age: 21 +/- 1.6 years), but two individuals met the exclusion criteria and were therefore excluded. Consequently, there were 29 participants remaining (age: 21 +/- 1.7 years), all of whom were female. Among the 28 myopic participants, subjective refractive error (spherical equivalent) ranged from -1.25D to -9.875D, with an average interocular difference of 0.76D +/- 0.65D. The single hyperopic participant had subjective refractive errors of 3.625D and 5.5D in each eye, with an interocular difference of 1.875D. Axial lengths of the right eye in myopic participants ranged from 23.52mm to 26.76mm, with an average interocular difference of 0.03mm +/- 0.31mm. The axial lengths of the hyperopic participant's eyes were 21.89mm and 21.39mm, respectively. At a distance of 5 meters, 12 participants had exophoria, 17 had orthophoria, and none had esophoria. At a distance of 30 centimeters, 25 participants exhibited exophoria, 1 had orthophoria, and 3 had esophoria. Among the 29 participants, 10 were confirmed to have left-eye dominance. All participants had 0 percent baseline aniseikonia, and baseline stereopsis was 40 seconds of arc for all.
Participant flow
Number of participants: 31
Number of participants meeting exclusion criteria: 2
Number of participants used in analysis: 29
Adverse events
None
Outcome measures
1) Primary Outcome Measures
Convergence: No changes in convergence were observed for either near or far responses.
Accommodation (Accommodation, Accommodative Lag): The accommodation decreased immediately after the introduction of the size lens but began to increase after 10 minutes of adaptation,
reaching maximum accommodation at 20 minutes, and then tended to return to the baseline.The accommodative lag initially increased right
after stimulation but gradually decreased until 20 minutes of adaptation, after which it showed a tendency to return to baseline.
Pupil Size: Regarding pupil size, there was a tendency for the pupil size to increase for both near and far responses immediately after wearing the size lens, but it returned to baseline immediately after the lens was removed.
2) Secondary Outcome Measures
Eye strain: Eye strain was confirmed; however, no associations were observed between eye fatigue and accommodation, pupil size, convergence, size lens, or refraction.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060807
