Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

October 29, 2015 updated by: Abbott Medical Optics

Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00

The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ahaus, Germany, 48683
        • Augenarzte Gemeinschaftspraxis Ahaus
      • Heidelberg, Germany, 69120
        • University Eye Clinic
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann gGmbH
      • Tubingen, Germany, 72076
        • University Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral cataracts and otherwise healthy eyes
  • visual potential of Decimal 0.8 in each eye

Exclusion Criteria:

  • any medications affecting vision
  • any chronic disease/illness that would affect risk to subject or outcomes of the study
  • any ocular pathology/abnormalities that may affect visual outcomes or confound study results
  • desire for monovision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifocal Intraocular Lens
ZMB00 multifocal intraocular lens
Device: One-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Other Names:
  • Model ZMB00
Active Comparator: Monofocal Intraocular Lens
ZCB00 monofocal intraocular lens
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Other Names:
  • ZCB00

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Time Frame: 4-6 Months
Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
4-6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Time Frame: 4-6 months
4-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Investigators

  • Principal Investigator: Peter Szurman, PD Dr. med.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIOL-105-TMF1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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