NCT00625313

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Hoya Surgical Optics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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 aphakia following cataract extraction.

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 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.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	HMY Model YA-60BB IOL	Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-02-28
• Last updated: 2015-08-19

Locations

1 site across 1 country: United States