presbyopia
Conditions
Interventions
Wearing study lenses "MyDay MF"
Sponsors
Kodama Yuji
Chikara Saito
CooperVision Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) He/she is at least 42 years of age when giving his/her informed consent 2) He/she is presbyopia 3) He/she habitually wears any of the following SCLs for at least 8 hours a day, 5 days a week until he/she gave consent - Daily disposable sphere soft contact lenses (Any brand) - Multifocal silicone hydrogel lenses "Dailies Total 1 MF" - Multifocal hydrogel lenses "Proclear 1 Day MF" 4) He/she can achieve a corrected distance visual acuity of at least 0.9 (decimal visual acuity) in each eye through refractive correction with spherocylindrical lenses 5) He/she has sphere power of +3.00~-8.00 when taking into account vertex distance 6) He/she has refractive astigmatism (cylindrical power) no higher than 1.00D from a manifest refraction 7) He/she requires a reading addition of at least +0.75D and no more than +2.50D from a manifest refraction 8) He/she is willing to undergo a medical examination on the specified examination date 9) He/she understood the information sheet and was able to give his/her voluntary written consent.
Exclusion criteria
Exclusion criteria: 1) He/she has worn hard contact lenses within 30 days before giving his/her consent 2) He/she has undergone refractive error surgery 3) He/she who has had an aphakic intraocular or intraocular lens implanted in his/her eye(s) 4) He/she is evaluated by slit lamp to have anterior ocular complications evaluated to be 3 or higher on the Efron Grading Scales 5) He/she is not satisfied with his/her visual quality with a single adjustment to sphere power of study lenses at baseline 6) He/she who has the following ophthalmic diseases - Acute and subacute inflammation of the anterior chamber of the eye - Ocular infection - Uveitis - Decreased corneal sensitivity - Eyelid abnormalities 7) He/she who has dry-eye symptoms and lacrimal apparatus disease to an extent that may cause issues in wearing lenses 8) He/she who has allergic diseases that may impact wearing lenses 9) He/she who usually resides in a dry environment 10) He/she who resides in an environment where dust and chemicals, etc. easily enter the eyes 11) He/she who is unable to follow the physician's instructions 12) He/she who is unable to use the lenses in an appropriate manner 13) He/she who is unable to follow lens care regimen 14) She self-reports as pregnant, lactating, or taking oral contraceptives 15) He/she who is participating in other clinical trials or studies 16) Anyone who is determined by the Co-Principal Investigators or others to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall satisfaction for study lens | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall satisfaction for lens handling of study lens | — |
Contacts
Public ContactYuji Kodama
Kodama Eye Clinic
Outcome results
None listed