Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens (HMY)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-center, Single-phase, Non-randomized, Open-label Study to Assess the Safety and Efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) for the Correction of Aphakia Following Phacoemulsification Cataract Extraction|
- Best Corrected Visual Acuity [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
- Adverse events/complications [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: HMY Model YA-60BB IOL
Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.
Device: HMY Model YA-60BB IOL
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
Other Name: Hoya HMY Acrylic Foldable 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625313
|United States, California|
|Contact Hoya Surgical Optics, Inc. for Trial Locations|
|Chino Hills, California, United States, 91709|
|Study Chair:||Steven L. Ziemba, M. Sc||Hoya Surgical Optics / Fullerton Regulatory & Clinical|