NCT00747227

Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)

Clinical Evaluation of a Modified Light Transmission IOL

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).

Detailed description

The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	modified light transmission intraocular lens	violet visible light blocking acrylic intraocular lens
DEVICE	monofocal acrylic intraocular lens	conventional hydrophobic acrylic intraocular lens

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-09-05
• Last updated: 2011-11-11
• Results posted: 2011-11-11

Locations

11 sites across 1 country: United States