The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.
A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
617
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, United States
Best Corrected Visual Acuity
Time frame: 12 months postoperative
Adverse events/complications
Time frame: 12 months postoperative
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