臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 12, 2022
Last modified on	Feb. 07, 2023
Trial ID	jRCTs032220268

Scientific Title	Exploratory study of intraocular pressure changes in the new self-measuring tonometer "tap eye" in normal and glaucoma patients
Public Title	Exploratory study of intraocular pressure changes in the new self-measuring tonometer "tap eye" in normal and glaucoma patients

Contact for Scientific Queries	Name	Teshigawara Tsuyoshi
	Affiliation	Yokohama Tsurumi Chuo Eye Clinic
	Address	1-2-1 Tsurumi Chuo, Tsurumi-ku, Yokohama-shi, Kanagawa
	Telephone	+81-45-508-1017
	E-mail	teshitake@gmail.com
Contact for Public Queries	Name	Kitamura Akira
	Affiliation	Yokohama Tsurumi Chuo Eye Clinic
	Address	1-2-1 Tsurumi Chuo, Tsurumi-ku, Yokohama-shi, Kanagawa
	Telephone	+81-45-508-1017
	E-mail	tsurumi.chuoh.eye.cs@gmail.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 12, 2022
Actual date of first enrollment		Dec. 04, 2022
Target sample size		100
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Cases that the principal investigator has determined that the test can be conducted. Prior to entry into this study, consent must be made by signing the explanatory consent form. The following conditions are the eligibility criteria Normal eye and glaucoma eye Glaucoma study subjects do not need to interrupt routine eye drop treatment. Age:18 years old or older Gender:no restrictions
	Exclusion Criteria	Research subjects who fall under one or more of the following items will be excluded from this study: (a) Less than one month after eye surgery (b) When there is a possibility that an ophthalmologist consultation is required during the clinical research period (c) In addition, when the Principal Investigator judges that the Principal Investigator is inappropriate as the subject of this research
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		glaucoma
Intervention(s)		The study subjects used the research instruments tap-eye tonometer and the control instruments GAT and NCT. The observation period is one month, and two examinations are carried out baseline and one month later.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Correlation coefficient with other tonometer (coefficient of determination: R2) The correlation coefficient when compared with this instrument and the recognized ocular pressure gauge (GAT, NCT) is evaluated. At that time, the evaluation index showed a statistically significant correlation following the previously published paper
Secondary Outcome(s)		1) Coincidence rate of change in intraocular pressure over time 2) Reproducibility in the same study subjects

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Toneasy, Inc.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Hattori Clinic
Address	Bessho, Hachioji-shi, Tokyo, Japan, Tokyo
Telephone	+81-3-3470-3360
E-Mail	reception-office@hattori-crb.com
Approval Status	Approval
Date of approval	Aug. 10, 2022

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Feb. 07, 2023	(this page)	Changes
3	Nov. 01, 2022	Detail	Changes
2	Nov. 01, 2022	Detail	Changes
1	Aug. 12, 2022	Detail

List of change history