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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
One-Piece Tecnis Multifocal IOL
One-Piece Tecnis monofocal IOL, Model ZCB00
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Augenarzte Gemeinschaftspraxis Ahaus
  • University Eye Clinic
  • Klinikum Ernst von Bergmann gGmbH
  • University Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multifocal Intraocular Lens

Monofocal Intraocular Lens

Arm Description

ZMB00 multifocal intraocular lens

ZCB00 monofocal intraocular lens

Outcomes

Primary Outcome Measures

Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
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.

Secondary Outcome Measures

Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity

Full Information

First Posted
June 17, 2010
Last Updated
October 29, 2015
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01210807
Brief Title
Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
Official Title
Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifocal Intraocular Lens
Arm Type
Experimental
Arm Description
ZMB00 multifocal intraocular lens
Arm Title
Monofocal Intraocular Lens
Arm Type
Active Comparator
Arm Description
ZCB00 monofocal intraocular lens
Intervention Type
Device
Intervention Name(s)
One-Piece Tecnis Multifocal IOL
Other Intervention Name(s)
Model ZMB00
Intervention Description
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Intervention Type
Device
Intervention Name(s)
One-Piece Tecnis monofocal IOL, Model ZCB00
Other Intervention Name(s)
ZCB00
Intervention Description
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Primary Outcome Measure Information:
Title
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Description
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.
Time Frame
4-6 Months
Secondary Outcome Measure Information:
Title
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Time Frame
4-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Szurman, PD Dr. med.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augenarzte Gemeinschaftspraxis Ahaus
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
University Eye Clinic
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gGmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
University Eye Clinic
City
Tubingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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