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

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. Identifier: NCT00876707
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : July 2, 2010
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Astigmatism Device: Tecnis implant Device: ReSTOR implant Device: ReZoom implant Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00876707

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

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Responsible Party: Marcony Rodrigues de Santhiago, University of São Paulo Identifier: NCT00876707     History of Changes
Other Study ID Numbers: 0088/09
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: April 2009
Keywords provided by University of Sao Paulo:
multifocal IOL
modulation transfer function
intraocular lenses
wavefront data
Visual performance
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Refractive Errors