臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 18, 2024
Last modified on	Sept. 18, 2024
Trial ID	jRCT1032240342

Scientific Title	Study of Intraocular Lens Constants for the Intraocular Lens HOYA Vivinex Impress Implanted Eyes
Public Title	Study of Intraocular Lens Constants for the Intraocular Lens HOYA Vivinex Impress Implanted Eyes

Contact for Scientific Queries	Name	Osakabe Yasuhiro
	Affiliation	HOYA CORPORATION Medical Division
	Address	Nakano Central Park South Building 6F 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan
	Telephone	+81-359132347
	E-mail	yasuhiro.osakabe@hoya.com
Contact for Public Queries	Name	Goto Yusuke
	Affiliation	HOYA CORPORATION Medical Division
	Address	Nakano Central Park South Building 6F 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan
	Telephone	+81-359132347
	E-mail	yusuke.goto@hoya.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 18, 2024
Actual date of first enrollment
Target sample size		900
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who are 22 years old or older and who are undergoing cataract extraction with phacoemulsification and aspiration 2) Patients who are having XY1-EM implanted 3) Patients whose calculated spherical lens power is +6.0 D or higher and +30.0 D or lower 4) Patients whose postoperative corrected visual acuity can be expected to be 0.7 or better 5) Patients whose preoperative corneal astigmatism is below 1.0 D 6) Patients who can be followed-up with after surgery
	Exclusion Criteria	1) Patients who are having another ophthalmologic surgery within one month after the intraocular lens implantation 2) Patients who have a history of refractive surgery 3) Patients who have a history of any eye disease or ocular comorbidities that significantly affect their visual function 4) Patients who the principal investigator, etc., deems not appropriate as a study subject due to an accompanying general disease or eye disease
	Age Minimum	22age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cataract
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		IOL constant per intraocular lens formula by biometers
Secondary Outcome(s)		1) Transition of uncorrected distance visual acuity 2) Post-op month 1 uncorrected intermediate visual acuity 3) Post-op month 1 uncorrected near visual acuity 4) Transition of postoperative refractive errors 5) Defects and adverse events

Primary Sponsor	HOYA CORPORATION

Source of Monetary Support / Secondary Sponsor	HOYA CORPORATION
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Non-Profit Organization MINS Research Ethics Committee
Address	5-20-9-401, Mita, Minato-ku, Tokyo,Japan, Tokyo, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	Mar. 07, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none