NCT00747565

Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

Detailed description

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Tecnis ZM900 Multifocal Intraocular Lens	Investigational intraocular lens
DEVICE	CeeOn 911A monofocal IOL	Monofocal Control IOL

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-01-01
• Completion: 2008-11-01
• First posted: 2008-09-05
• Last updated: 2025-02-04
• Results posted: 2010-12-02