UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024869
Receipt No. R000028622
Scientific Title Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
Date of disclosure of the study information 2016/11/18
Last modified on 2018/05/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hiroshi Sasaki
Organization Kanazawa Medical University
Division name Department of Ophthalmology
Zip code
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
Middle name
Last name Hiroshi Sasaki
Organization Kanazawa Medical University
Division name Department of Ophthalmology
Zip code
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
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
2018 Year 05 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.