Unique ID issued by UMIN | UMIN000032278 |
---|---|
Receipt number | R000036793 |
Scientific Title | Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method |
Date of disclosure of the study information | 2018/04/16 |
Last modified on | 2021/10/21 15:38:15 |
Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Molded-RGP
Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Molded-RGP
Japan |
Patients using conventional oxygen-permeable hard contact lenses for more than five days a week
Ophthalmology |
Others
NO
The three-month regular exchange type oxygen-permeable hard contact lens by the mold process, while performing a regular exchange for one year, subjective symptoms, anterior eye findings, other haptic inspection, lens fitting, etc., The purpose of this study is to compare conventional oxygen-permeable hard-to-use lenses.
Safety,Efficacy
Comparative evaluation of test items for three-month regular-exchange oxygen-permeable hard contact lenses by conventional oxygen-permeable hard contact lenses and moldprocess
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
Three-month periodic exchange of oxygen-permeable hard contact lens by molding method
20 | years-old | <= |
60 | years-old | >= |
Male and Female
1)Patients using conventional oxygen-permeable hard contact lenses for more than five days a week
2)Patients who came to the hospital in a state of conventional oxygen-permeable hard contact lenses with over six months of use during the first inspection.
3)Conventional oxygen-permeable hard contact lenses are spherical lenses (not for perspective or astigmatism)
4)Patients who wear conventional oxygen-permeable hard contact lenses throughout the day (patients who are not in continuous wear)
5)Patients aged 20 years and under 60 years of age at the time of consent acquisition
6)A patient who understands the contents of the consent document and is able to consent in the document of the person
7)Patient who can come to the observation day by the instruction of the researcher
8)Men and women do not matter.
1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye
2)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research
3)Patients judged by other research managers or researchers as inappropriate to implement this research safely
100
1st name | Takashi |
Middle name | |
Last name | Suzuki |
Ishizuchi Eye Clnic
Director
7920081
1-8-30 Shonaicyo Niihama-city Ehime
0898-33-3069
t-suzuki@ishizuchi-eye-clinic.jp
1st name | Takashi |
Middle name | |
Last name | Suzuki |
Ishizuchi Eye Clnic
Director
7920811
1-8-30 Shonaicyo Niihama-city Ehime
0898-33-3069
t-suzuki@ishizuchi-eye-clinic.jp
Ishizuchi Eye Clnic
Menicon
Profit organization
Riverside IRB
Minamisitijounishi2-1 Chuoku Sapporro
0115212321
rinrishinsa@riversideclinic.or.jp
NO
2018 | Year | 04 | Month | 16 | Day |
Published
93
Completed
2018 | Year | 02 | Month | 17 | Day |
2018 | Year | 02 | Month | 27 | Day |
2018 | Year | 04 | Month | 16 | Day |
2021 | Year | 10 | Month | 01 | Day |
2018 | Year | 04 | Month | 16 | Day |
2021 | Year | 10 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036793