UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042580 |
|---|---|
| Receipt number | R000048598 |
| Scientific Title | Verification of refractive values for different ocular refraction techniques and construction of prediction models using artificial intelligence |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/12/01 17:14:02 |
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Basic information
Public title
Verification of refractive values for different ocular refraction techniques and construction of prediction models using artificial intelligence
Acronym
Verification of refractive values for different ocular refraction techniques and construction of prediction models using artificial intelligence
Scientific Title
Verification of refractive values for different ocular refraction techniques and construction of prediction models using artificial intelligence
Scientific Title:Acronym
Verification of refractive values for different ocular refraction techniques and construction of prediction models using artificial intelligence
Region
| Japan |
Condition
Condition
Refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nowadays,refractive correction, such as eyeglasses,not only improves vision, but also requires faster and more accurate methodologies to be established. However, it is not clear how much the values vary between methods and other factors, and whether expensive equipment is truly accurate in its measurement. In addition, patients and eyeglass purchasers may find it troublesome to measure subjective refractive values by responding to repeated questions while changing lenses.
In addition, the current practice of adjusting eyeglass power to a weaker value based on the experience of the wearer and expecting the central system to adapt to the eyeglass after the wearer has worn it is a highly uncertain method. As a result, it takes a lot of time to determine a comfortable pair of eyeglasses, and if they still do not fit, it is not uncommon for inefficiencies to result in the replacement of the lenses.
Therefore, we aim to establish a highly accurate methodology in a shorter period of time by verifying refractive values for different ocular refraction testing methods and building a prediction model using artificial intelligence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gender, date of birth, daily refractive method and condition, current and previous ophthalmological history, naked visual acuity, corrected visual acuity (including in downward vision), interpupillary distance, adjustment ability, subjective and other refractive values
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
| Device,equipment |
Interventions/Control_1
Subjective, altruistic refractive measurement,Accommodation,Pupil Distance.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Corrected vision 1.0 or better
Key exclusion criteria
Ocular diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | Kawamorita |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa, Japan 252-0373
TEL
0427789662
kawa2008@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa, Japan 252-0373
TEL
0427789662
Homepage URL
kawa2008@kitasato-u.ac.jp
Sponsor or person
Institute
The Kitasato Institute
Institute
Department
Personal name
Funding Source
Organization
HOYA Corporation.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasto University Hospital,
Address
IRB Office
Tel
042-778-9602
a-soumu@kitasato-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
Other administrative information
Date of disclosure of the study information
| 2021 | 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
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
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | 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
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048598
