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Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses (IOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876707
First Posted: April 7, 2009
Last Update Posted: July 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Condition Intervention Phase
Cataract Astigmatism Device: Tecnis implant Device: ReSTOR implant Device: ReZoom implant Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • visual acuity, wavefront data and modulation transfer function [ Time Frame: 30, 90 and 120 days after surgery ]

Secondary Outcome Measures:
  • contrast sensitivity [ Time Frame: 90 days after surgery ]

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tecnis Device: Tecnis implant
Implant of diffractive multifocal IOL Tecnis
Active Comparator: ReSTOR Device: ReSTOR implant
Implant of multifocal IOL ReSTOR
Active Comparator: ReZoom Device: ReZoom implant
Implant of multifocal IOL ReZoom

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria:

  • Any ocular diseases, such as:

    • corneal opacities or irregularity
    • dry eye
    • amblyopia
    • anisometropia
    • glaucoma
    • retinal abnormality
  • Surgical complications
  • IOL tilt
  • IOL decentration greater than 0.4 mm (estimated by retroillumination)
  • Incomplete follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876707


Locations
Brazil
University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
  More Information

Responsible Party: Marcony Rodrigues de Santhiago, University of São Paulo
ClinicalTrials.gov Identifier: NCT00876707     History of Changes
Other Study ID Numbers: 0088/09
First Submitted: April 3, 2009
First Posted: April 7, 2009
Last Update Posted: July 2, 2010
Last Verified: April 2009

Keywords provided by University of Sao Paulo:
wavefront
multifocal IOL
modulation transfer function
intraocular lenses
wavefront data
Visual performance

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors