臨床研究等提出・公開システム

Japanese

Date of registration	April. 27, 2024
Last modified on	April. 27, 2024
Trial ID	jRCT1072240010

Scientific Title	Evaluation of visual function after implantation of Impress intraocular lens
Public Title	Evaluation of visual function after implantation of Impress intraocular lens

Contact for Scientific Queries	Name	Mori Yosai
	Affiliation	Miyata Eye Hospital
	Address	6-3 Kurahara Miyakonojo Miyazaki
	Telephone	+81-986-22-1441
	E-mail	yosai730@gmail.com
Contact for Public Queries	Name	Yagi Akiko
	Affiliation	Miyata Eye Hospital
	Address	6-3 Kurahara Miyakonojo Miyazaki
	Telephone	+81-986-22-1441
	E-mail	officeplusi2012@mbr.nifty.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 01, 2023
Actual date of first enrollment		Mar. 02, 2024
Target sample size		25
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with cataracts 2) Patients with corneal astigmatism not exceeding 1.0D 3) Patients with axial length between 22 and 26mm 4) Patients desiring binocular emmetropia 5) Patients signed the informed consent form 6) Patients scheduled for second eye cataract surgery within 30 days after first eye cataract surgery
	Exclusion Criteria	1) Patients with or suspected to have disease affecting visual acuity except for cataract at the time of preoperative examination in the study eye 2) Patients who are regarded as unsuitable for this study by the investigator 3) Patients expressed refusal to participate in this study 4) Patients who do not meet the foregoing inclusion criteria 5) Patients in whom intraoperative complications affecting visual acuity have occurred, except for the preoperative exclusion criteria mentioned above
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cataract
Intervention(s)		A group: Implantation of HOYA Vivinex iSert XY 1-EM IOL B group: Implantation of HOYA Vivinex iSert XY1-XY1 IOL
Health Condition(s) Keyword		Cataract
Intervention(s) Keyword		Intraocular Lens Implantation
Health Condition(s) Code		Cataract
Intervention(s) Code		D019654
Primary Outcome(s)		Uncorrected/ corrected all-distance visual acuity at 3 months after surgery (binocular visual acuity)
Secondary Outcome(s)		1) Uncorrected/ corrected all-distance visual acuity at 3 months after surgery (monocular visual acuity) 2) Contrast sensitivity at 3 months after surgery 3) Evaluation of QOV (questionnaire) 4) Prescription rate of glasses 5) Incidence of surface scattering

Primary Sponsor	Miyata Eye Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Clinical Research Ethics Review Committee, Miyata Eye Hospital, Meiwa-kai, Inc.
Address	6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan, Miyazaki
Telephone	+81-986-22-1441
E-Mail	ushihama@miyata-med.ne.jp
Approval Status	Approval
Date of approval	Nov. 29, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none