Unique ID issued by UMIN | UMIN000024869 |
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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 |
Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
FineVision
Clinical trials of FineVision (PhysIOL) trifocal intraocular lens
FineVision
Japan |
Cataract causing impaired visual function
Ophthalmology |
Others
NO
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.
Safety,Efficacy
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.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
FineVision(Micro F), FineVision(Pod F), FineVision(Toric)
1 | years-old | <= |
100 | years-old | >= |
Male and Female
Patients who are expected to achieve improved visual function by cataract surgery within the range of IOL diopters.
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.
50
1st name | Sasaki |
Middle name | |
Last name | Hiroshi |
Kanazawa Medical University
Department of Ophthalmology
9200293
1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
076-286-2211
ophthal@kanazawa-med.ac.jp
1st name | Sasaki |
Middle name | |
Last name | Hiroshi |
Kanazawa Medical University
Department of Ophthalmology
9200293
1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
076-286-2211
ophthal@kanazawa-med.ac.jp
Kanazawa Medical University
none
Self funding
Kanazawa Medical University,Clinical Trials Clinical Trials Center
1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN
076-218-8347
tiken@kanazawa-med.ac.jp
NO
2016 | Year | 11 | Month | 18 | Day |
Partially published
33
Completed
2015 | Year | 07 | Month | 28 | Day |
2015 | Year | 08 | Month | 27 | Day |
2015 | Year | 12 | Month | 15 | Day |
2020 | Year | 11 | Month | 22 | Day |
2016 | Year | 11 | Month | 16 | Day |
2020 | Year | 11 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028622
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