UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
Acronym	FineVision
Scientific Title	Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
Scientific Title:Acronym	FineVision
Region	Japan

Condition
Condition	Cataract causing impaired visual function
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The monofocal intraocular lens (IOL), commonly selected for use in cataract surgery, is included among items covered by Japan's national health insurance (NHI). However, as it has fixed focus at one distance of either near, intermediate or far, most people need to use glasses to correct for the other distances. To counter this disadvantage the multifocal IOL, which can focus at near and far distances, was approved for use in October 2008 in Japan, though it is still not covered by Japan's NHI. Our hospital is listed as a regional facility for advanced medical services, and we have inserted multifocal IOLs into 299 eyes as of July, 2015. In this study, we will conduct clinical trials using the trifocal IOL, which fixes focus on near, intermediate, and far distances, as well as corrects for astigmatism. As the trifocal IOL is expected to achieve better postoperative visual function than the multifocal IOL, there is a strong possibility of high levels of patient satisfaction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity (VA; non-corrected VA, corrected VA, contrast VA, functional VA, near distance VA, etc.)is measured the next day after surgery, one week, one month, three months, six months, one year, then every year.
Key secondary outcomes	refraction, accommodative power, form of anterior ocular segment, corneal endothelium, corneal form, corneal thickness, pupil diameter, forward light scattering, backward light scattering, higher-order aberrations, retinal image contrast, diagnosis of anterior ocular segment by slit-lamp microscopy, measurement of anterior chamber protein content

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	FineVision(Micro F), FineVision(Pod F), FineVision(Toric)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are expected to achieve improved visual function by cataract surgery within the range of IOL diopters.
Key exclusion criteria	Patients with a history of ocular diseases including: age-related macular degeneration of the macula; advanced glaucoma (severe visual field abnormality); keratoconus; ruptured Zinn's zonule and other corneal diseases. Patients with a history of cornea refractive surgery and patients excluded by a responsible doctor for other reasons to be stated.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Sasaki Middle name Last name Hiroshi
Organization	Kanazawa Medical University
Division name	Department of Ophthalmology
Zip code	9200293
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
TEL	076-286-2211
Email	ophthal@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Sasaki Middle name Last name Hiroshi
Organization	Kanazawa Medical University
Division name	Department of Ophthalmology
Zip code	9200293
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
TEL	076-286-2211
Homepage URL
Email	ophthal@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanazawa Medical University,Clinical Trials Clinical Trials Center
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
Tel	076-218-8347
Email	tiken@kanazawa-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 28 Day
Date of IRB	2015 Year 08 Month 27 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date	2020 Year 11 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 16 Day
Last modified on	2020 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028622