UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055220 |
|---|---|
| Receipt number | R000063060 |
| Scientific Title | Research on the Development of Infant Vision Screening Devices Using Eye Tracking Devices |
| Date of disclosure of the study information | 2024/08/18 |
| Last modified on | 2024/08/11 23:32:21 |
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Basic information
Public title
Research on the Development of Screening Equipment to Improve Amblyopia Detection Rate
Acronym
Research on the Development of Screening Equipment to Improve Amblyopia Detection Rate
Scientific Title
Research on the Development of Infant Vision Screening Devices Using Eye Tracking Devices
Scientific Title:Acronym
Research on the Development of Infant Vision Screening Devices Using Eye Tracking Devices
Region
| Japan |
Condition
Condition
Children 0-7 years old
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Children's visual acuity develops by the age of eight, but refractive error or eye disease before that age can impede visual development and result in amblyopia. Many cases of amblyopia can be treated with early detection, but late detection can lead to lifelong visual impairment. Early detection of amblyopia is therefore important. However, measuring visual acuity in infants and toddlers is difficult because infants and toddlers do not understand visual acuity tests using Landolt rings, which are performed on adults.
Since infants have a tendency to prefer to look at indicators that have a pattern, the preferential looking (PL) method is used to measure visual acuity using this property.
The PL method requires the examiner's skill to measure visual acuity by observing the infant's gaze, which is not available in many facilities, and also relies on the examiner's subjective judgment. Therefore, infants often cannot be screened and are left for observation, delaying the detection of amblyopia.
If the PL method, which can only be performed at a limited number of facilities, could be mechanized to allow for more widespread and more easily administered, it could lead to the early detection of amblyopia.
Therefore, the purpose of this study is to analyze the visual acuity measurement by the Teller Acuity Card (TAC), which is often used clinically among the PL methods, using a mechanical algorithm, and to verify whether the test results can be similar to those obtained by the current TAC method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The inferiority / non-inferiority of the mechanical algorithm according to the TAC method and the conventional TAC method.
Key secondary outcomes
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
| 1 | months-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants attending Nagoya University Hospital are included in the study.
Key exclusion criteria
Exclude cases in which vision is without light perception.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Yasuda |
Organization
Nagoya University Hospital
Division name
ophthalmology
Zip code
466-8560
Address
65, Tsurumai-chou, Shouwa-ku, Nagoya, Aichi, JAPAN
TEL
052-744-2275
yasuda.sayuri.i2@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Yasuda |
Organization
Nagoya University Hospital
Division name
ophthalmology
Zip code
466-8560
Address
65, Tsurumai-chou, Shouwa-ku, Nagoya, AIchi, JAPAN
TEL
052-744-2275
Homepage URL
yasuda.sayuri.i2@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Sayuri Yasuda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Life Ethics Review Committee
Address
65, Tsurumai-chou, Shouwa-ku, Nagoya, Aichi, JAPAN
Tel
052-744-2423
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 18 | 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
| 2024 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
This will be conducted as a prospective study.
Subjects will be patients who visited Nagoya University Hospital between September 15, 2024 and March 31, 2029, and will undergo two types of visual acuity tests.
One is the examiner's conventional preferred looking (PL) method, which is the usual method of vision testing for infants, and the other is the mechanized PL method.
Mechanical PL is being developed in this research, and it mechanizes the examiner's PL method by using an eye-tracking device to capture eye movements toward the indicators displayed on the screen.
The obtained measurement results, age, gender, and other data will be recorded and statistically analyzed. Statistical methods such as Accuracy/ Precision/ Recall and ROC curves will be used to evaluate the accuracy of the mechanical PL method compared to the conventional PL method.
Management information
Registered date
| 2024 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063060
