臨床研究等提出・公開システム

Date of registration	Mar. 11, 2024
Last modified on	Mar. 11, 2024
Trial ID	jRCT1050230199

Scientific Title	Retinal image analysis using ultra-high resolution fundus imaging devices utelizing adaptive optics
Public Title	Retinal image analysis using adaptive optics devices

Contact for Scientific Queries	Name	Mandai Michiko
	Affiliation	Kobe City Hospital Organization Kobe City Eye Hospital
	Address	2-1-8, Minatojima Minamimachi, Chuo-ku, Kobe-shi, Hyogo
	Telephone	+81-78-381-9876
	E-mail	e_lab.mandai@kcho.jp
Contact for Public Queries	Name	Mandai Michiko
	Affiliation	Kobe City Hospital Organization Kobe City Eye Hospital
	Address	2-1-8, Minatojima Minamimachi, Chuo-ku, Kobe-shi, Hyogo
	Telephone	+81-78-381-9876
	E-mail	e_lab.mandai@kcho.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Jan. 11, 2024
Actual date of first enrollment		Feb. 15, 2024
Target sample size		220
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Subjects (1) patients with retinochoroidal diseases, (2) patients with retinitis pigmentosa, (3) patients with glaucoma, (4) patients with uveitis, (5) patients scheduled for transplantation of iPS cell-derived retinal cells, (6) patients after iPS cell-derived retinal cell transplantation. In addition, (7) healthy volunteers will be used to photograph normal eyes. 2. Selection criteria (1) Persons 20 years of age or older. (2) Persons who have consented to participate in this research.
	Exclusion Criteria	(1) Persons judged by the principal researcher to be inappropriate as research subjects (2) The following persons fall under the contraindications and prohibitions of using the AO fundus imaging device: Those with a history of photosensitivity; those who have recently received photodynamic therapy (PDT) (Please refer to the package insert of the photosensitive substance administered for the prohibited period);those who are taking medicines that may cause photosensitivity
	Age Minimum	20age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		retinochoroidal diseases, retinitis pigmentosa, glaucoma, uveiti .etc
Primary Outcome(s)		1) Morphological observation and quantitative evaluation of photoreceptor cells (cell density, etc.) using m2OCT 2) Morphological observation and quantitative evaluation of retinal pigment epithelial cells using TFI-rtx1 (cell density, etc.) 3) Comparison of captured images of rtx1 and TFI-rtx1

Primary Sponsor	Kobe City Hospital Organization Kobe City Eye Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	The Kobe City Medical Center General Hospital Research Ethics Committee
Address	2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, Hyogo
Telephone	+81-78-302-5176
E-Mail	rinken@kcho.jp
Approval Status	Approval
Date of approval	Dec. 25, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none