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Clinical Investigation of Expanded Designs of a Multifocal IOL

NCT01714635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2015-03-17

Study results available
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Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.

Conditions

  • Cataract

Interventions

DEVICE

Tecnis Multifocal Intraocular Lens

DEVICE

Monofocal Intraocular Lens

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Kendra Hileman, PhD · Abbott Medical Optics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-10-31
Completion
2014-07-31

Countries

  • United States
  • United Kingdom

Study Locations

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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 NCT01714635 on ClinicalTrials.gov