臨床研究等提出・公開システム

Date of registration	Sept. 10, 2024
Last modified on	Sept. 10, 2024
Trial ID	jRCT1030240325

Scientific Title	The effect of brightness on near visual function in early presbyopia
Public Title	The effect of brightness on near visual function in early presbyopia

Contact for Scientific Queries	Name	Negishi Kazuno
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-5363-3821
	E-mail	kazunonegishi@keio.jp
Contact for Public Queries	Name	Kubota Miyuki
	Affiliation	Shonan Keiiku Hospital
	Address	4360 Endo, Fujisawa-shi, Kanagawa, Japan
	Telephone	+81-466-48-0050
	E-mail	myu.kubota@keio.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 10, 2024
Target sample size		60
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Age 20 years and above, up to 35 years; and 40 years and above, up to 55 years 2) Distance-corrected visual acuity of 1.0 or better in each eye, and distance-corrected near visual acuity of 0.5 or better with both eyes 3) Participants who can operate an iPhone and use applications without any issues. 4) Participants who are able to provide written consent after understanding the content of this study.
	Exclusion Criteria	1) Systemic or ocular diseases affecting visual function 2) History of internal ocular or refractive surgery 3) Dry eye (corneal epithelial scoring of 3 or higher or presence of subjective symptoms) 4) Difficulty in accurate communication 5) Participants who are judged to be inappropriate as a cooperator by a doctor in charge.
	Age Minimum	20age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Healthy individuals / Presbyopia
Primary Outcome(s)		Amount of change in near visual acuity and near additional power associated with changes in brightness environment
Secondary Outcome(s)		-Amplitude of accommodation -Pupillary area -Questionnaire on subjective eye symptoms -Near functional visual acuity

Primary Sponsor	Department of Ophthalmology Keio University School of Medicine

Source of Monetary Support	Research Grant from Kanagawa Ophthalmologists Association
Secondary Sponsor	Not applicable

Source of Monetary Support	Grant from the Foundation for Total Health Promotion
Secondary Sponsor	Not applicable

Source of Monetary Support	Department of Ophthalmology Keio University School of Medicine Fund of New Education Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan, Tokyo, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-nintei-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Aug. 26, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none