CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 470 enrolled
Drug / intervention
Tecnis ZM900 Multifocal Intraocular Lens +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00747565
NCT00747565N/ACompleted
CompareCT.gov

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)

Abbott Medical Optics·interventional·Posted Sep 5, 2008·Updated Feb 4, 2025

In Brief

A clinical study evaluating Tecnis ZM900 Multifocal Intraocular Lens and CeeOn 911A monofocal IOL for Cataract. Completed, enrolled 470 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2008
Enrollment StartNov 1, 2004
Primary CompletionJan 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.8 years ago

Interventions

Tecnis ZM900 Multifocal Intraocular Lensdevice

Investigational intraocular lens

CeeOn 911A monofocal IOLdevice

Monofocal Control IOL