臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 26, 2023
Last modified on	April. 01, 2024
Trial ID	jRCTs032230425

Scientific Title	Exploratory clinical study for early detection of glaucoma using novel evaluation device. (Exploratory clinical study for early detection of glaucoma using novel evaluation device.)
Public Title	Exploratory clinical study for early detection of glaucoma using novel evaluation device.

Contact for Scientific Queries	Name	Akiba Ryutaro
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-Ku, Chiba City, Chiba
	Telephone	+81-43-226-2124
	E-mail	akiba@chiba-u.jp
Contact for Public Queries	Name	Akiba Ryutaro
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-Ku, Chiba City, Chiba
	Telephone	+81-43-226-2124
	E-mail	akiba@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 26, 2023
Actual date of first enrollment
Target sample size		39
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	[Healthy subject] Subject meeting all of below conditions: 1. Age between 20 and 80 years. 2. Eyes with open angle 3. Eyes with best corrected decimal visual acuity of or above 0.5 4. Eyes with refractive error of less than -6 diopters (spherical) and -3 diopters (cylinder). 5. Subject must undergo through explanation of the study, then sign the written consent form upon subject's free will. 6. Eyes without diagnosis of glaucoma or preperimetric glaucoma. [Glaucoma subject] Must meet criteria 1-5 of healthy subjects, and have eyes diagnosed as glaucoma. [Preprimetric glaucoma subject] Must meet criteria 1-5 of healyh subjects, and have eyesdiagnosed as preperimetric glaucoma.
	Exclusion Criteria	1. Subject regarded as non-qualified by doctor in chief of the clinical study. 2. Eyes with history of ocular trauma, or intraocular surgery (Except for cataract and glaucoma with no surgical complications.) 3. Eyes with underlying retinal disease, uveitis, and non-glaucomatous optic neuritis. 4. History of optic chiasm disaese or demyelinating disease that affect visual field. 5. History of cognitive disase including Parkinson's diesase, Alzheimer's disease, and cerebral infarction. 6. Eyes with poor fixation upon Humphrey visual field test.
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy subjects, Glaucoma, Preperimetric glaucoma
Intervention(s)		Visual field testing with newly deveoped perimetry.
Health Condition(s) Keyword		glaucoma, preperimetric glaucoma
Intervention(s) Keyword
Health Condition(s) Code		D005901
Intervention(s) Code
Primary Outcome(s)		Correlation analysis between conventional humphrey fielad analyzer and the newly developed perimetry.
Secondary Outcome(s)		Correlation analysis between optical coherence tomography and newly developed perimetry.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	CREWT Medical Systems, Inc.
Secondary Sponsor	Not applicable

Source of Monetary Support	Clinical Research Initiation-Fund (of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 01, 2024	(this page)	Changes
1	Oct. 26, 2023	Detail

List of change history