UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024869
Receipt number R000028622
Scientific Title Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
Date of disclosure of the study information 2016/11/18
Last modified on 2020/11/22 09:15:14

* 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 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 or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



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

Value
https://center6.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