UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041991 |
|---|---|
| Receipt number | R000047926 |
| Scientific Title | Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2025/04/06 09:13:55 |
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Basic information
Public title
Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants
Acronym
Analysis of eye movement development in infants
Scientific Title
Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants
Scientific Title:Acronym
Analysis of eye movement development in infants
Region
| Japan |
Condition
Condition
strabismus
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which developmental stage of which eye movement is associated with strabismus onset in childhood by analysis of eye movements of infants without strabismus and infants with strabismus with an eye tracker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fixation stability
velocity of saccadic eye movement
binocular coordination of smooth pursuit
binocular coordination of convergence
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Recording eye movement by eye tracking device
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
| 3 | months-old | <= |
Age-upper limit
| 4 | years-old | > |
Gender
Male and Female
Key inclusion criteria
For those who meet the following (1) or (2)
(1) Normal person who is 3 months to less than 4 years old, has no strabismus / ocular motility disorder, and has no disease that may have strabismus / ocular motility disorder.
(2) Have strabismus between the ages of 3 months and 4 years (regardless of definitive diagnosis / suspected case, treatment history)
Key exclusion criteria
Exclude if any of the following items apply
(1) Those who do not wish to participate in this research
(2) Those with irregular pupils
(3) Left-right difference in aversive reaction or left-right difference in visual acuity of 3 levels or more
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | MIHARU |
| Middle name | |
| Last name | MIHARA |
Organization
University of Toyama
Division name
Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama
TEL
076-434-7363
miharu@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | MIHARU |
| Middle name | |
| Last name | MIHARA |
Organization
University of Toyama
Division name
Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama
TEL
076-434-7363
Homepage URL
miharu@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama
Tel
076-434-7681
rinri@adm.u-toyama.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
| 2020 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000047926&flwp_key=1008dXF5xT1
Publication of results
Partially published
Result
URL related to results and publications
https://www.jaapos.org/article/S1091-8531(24)00343-4/fulltext
Number of participants that the trial has enrolled
48
Results
In the intermittent exotropia(IXT) group(38 children), the peak velocity and gain of the adduction saccade tended to be greater than those of the abduction saccade, but not significantly. The no-strabismus group (10 children) exhibited a similar trend, with a stronger tendency in the dominant eye, reaching statistical significance.Both the children with IXT and children without strabismus showed a dominance of adduction in their saccades; however, this dominance was weaker in children with IXT.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with IXT and children without strabismus aged under 12 years were recruited children with IXT from the Department of Ophthalmology at Toyama University Hospital and children without strabismus as volunteers. Exclusion criteria were history of strabismus surgery or amblyopia and eye disease or neurological or systemic disease related to eye movement disorders.
Participant flow
Written informed consent was obtained from the parent or guardian of each participant after the experimental procedures were fully explained. An easy-to-understand explanation form for each of two age groups, children aged 4-6 years and those aged 7-12 years, was prepared for the purpose of acquiring assent from the children.
Adverse events
none
Outcome measures
Peak velocities and gain of saccades(adduction and abduction)
The saccade gain is the ratio of the saccade amplitude to the target amplitude.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047926
