臨床研究等提出・公開システム

Date of registration	June. 21, 2019
Last modified on	Oct. 01, 2022
Trial ID	jRCTs042190045

Scientific Title	The study of the ocular examination using adaptive optics scanning laser ophthalmoscope (AO-SLO study)
Public Title	AO-SLO study (AO-SLO study)

Completion date	Oct. 01, 2020
Result actual enrolment	11
Baseline Characteristics	Eleven patients had retinal disease. Age ranged from 25 to 58 years with a median age of 45 years. Four males and 7 females were included.
Participant flow	No participant flow
Adverse events	Nothing
Outcome measures	Evaluation was not possible due to the fact that 11 people were analyzed.
Brief summary	We planned to evaluate 200 patients with adaptive optics scanning laser ophthalmoscopy, but the study was terminated when 11 patients had been photographed. Therefore, we were not able to evaluate the effect of adaptive optics statistically, but we were able to observe the photoreceptor level generally from the fundus of 11 patients.
Date of posting of results summaries	Oct. 01, 2022

Plan to share IPD	No
Plan description	Nothing
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs042190045

Contact for Scientific Queries	Name	Ueno Shinji
	Affiliation	Nagoya University Graduate School of Medicine
	Address	Nagoya
	Telephone	+81-52-744-2275
	E-mail	ueno@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Ueno Shinji
	Affiliation	Nagoya University Graduate School of Medicine
	Address	65 Tsuruma-cho, Showa-ku, Nagoya
	Telephone	+81-52-744-2275
	E-mail	ueno@med.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 21, 2019
Target sample size		200
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	The person who approved to be examined using AO-SLO
	Exclusion Criteria	The person who denied to be examined using AO-SLO
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Any ocular disease and normal persons
Intervention(s)		Fundus examinations using un-approved adaptive optics scanning laser ophthalmoscope
Primary Outcome(s)		Resolution of the ocular tissue
Secondary Outcome(s)		Density of photoreceptor cells, vessel diameter, arterial wall thickness

Source of Monetary Support / Secondary Sponsor	NIDEK CO., LTD
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nagoya University Clinical Research Review Board
Address	65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	April. 24, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Oct. 01, 2022	(this page)	Changes
2	Aug. 13, 2021	Detail	Changes
1	June. 21, 2019	Detail

List of change history