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Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

NCT00747565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2025-02-04

Study results available
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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.

Conditions

  • Cataract

Interventions

DEVICE

Tecnis ZM900 Multifocal Intraocular Lens

Investigational intraocular lens

DEVICE

CeeOn 911A monofocal IOL

Monofocal Control IOL

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Mark Packer, M.D. · Drs. Fine, Hoffman and Packer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-01-31
Completion
2008-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747565 on ClinicalTrials.gov