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

Completed · Not applicable

Conditions studied: Aphakia

In brief

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.

Key facts

Study ID

NCT00625313

Run by

Hoya Surgical Optics, Inc.

People needed

617

Starts

2004-03-01

Expected to finish

2008-12-01

Last updated by the study team

2015-08-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Contact Hoya Surgical Optics, Inc. for Trial Locations — Chino Hills, California, United States

Full record on ClinicalTrials.gov

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