Status:
COMPLETED
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
Lead Sponsor:
Hoya Surgical Optics, Inc.
Conditions:
Aphakia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ap...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
617 Patients enrolled
Trial Details
Trial ID
NCT00625313
Start Date
March 1 2004
End Date
December 1 2008
Last Update
August 19 2015
Active Locations (1)
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1
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, United States, 91709