UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044916 |
|---|---|
| Receipt number | R000051308 |
| Scientific Title | Evaluation of binocular autorefractometer |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2021/07/20 16:28:01 |
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Basic information
Public title
Evaluation of binocular autorefractometer
Acronym
Evaluation of binocular autorefractometer
Scientific Title
Evaluation of binocular autorefractometer
Scientific Title:Acronym
Evaluation of binocular autorefractometer
Region
| Japan |
Condition
Condition
Strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The human eye is classified into normal, hyperopic, and myopic eyes according to the axial length and the refractive power of the cornea and lens. Since the ocular refractive power is constantly changing due to the simultaneous input of impulses to the ciliary muscles of both eyes and changes in the thickness of the lens, errors between measurements occur when the sampling rate is low. In recent years, improvements in the performance of image sensors have made it possible to measure the refractive power of approximately 3.0 mm diameter at the center of the pupil without a time lag when measuring one eye, but when measuring the another eye, the autorefractometer must be moved, resulting in a time lag between the measurements of the right eye and the left eye.
By measuring the refractive power of both eyes at the same time, the error in the refractive power of the left and right eyes can be reduced and the measurement time can be shortened. On the other hand, simultaneous measurement of refractive power in both eyes may cause off-axis aberration due to the effect of eye movement (convergence). Therefore, the purpose of this study is to use an autorefractometer that can measure the refractive power indices of both eyes at the same time and to compare it with a conventional instrument that can measure only a single eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Choromatic aberration, degree of phoria myopia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No ophthalmological disease other than refractive error.
Key exclusion criteria
Ophthalmic diseases other than refractive error
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Hirota |
Organization
Teikyo University
Division name
Department of Orthoptics, Faculty of Medical Technology
Zip code
1738605
Address
2-11-1 Kaga, Itabashi, Tokyo
TEL
0339641328
hirota.ortho@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Hirota |
Organization
Teikyo University
Division name
Department of Orthoptics, Faculty of Medical Technology
Zip code
1738605
Address
2-11-1 Kaga, Itabashi, Tokyo
TEL
0339641328
Homepage URL
hirota.ortho@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Topcon 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
Research Ethics Committee, Faculty of Medicine, Teikyo University
Address
2-11-1 Kaga, Itabashi, Tokyo
Tel
0339647256
turb-office@teikyo-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 | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | 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
Evaluate the refractive power of simultaneous binocular autorefractometer.
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051308
