Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens

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.

Inclusion criteria

• Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
• Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
• Patients must be at least 21 years of age.
• Patients must sign a written informed consent form.
• Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.

Exclusion criteria

• Patients with a history of/or clinical signs of any of the following sight-threatening conditions:

• Previous Retinal Detachment or retinal pathology in operative eye, only
• Macular Degeneration in either eye
• Macular Edema in either eye
• Persistent Iritis/Uveitis in operative eye, only
• Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
• Significant Corneal Disease in operative eye, only
• Proliferative Diabetic Retinopathy in either eye
• Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
• Patients who have best corrected vision worse than 20/200 in the fellow eye.
• Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
• Patients who have undergone previous cataract extraction and intraocular lens implantation.
• Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
• Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.