UMIN-CTR Clinical Trial

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
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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
Email	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
Email	hirota.ortho@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051308