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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00876707
First received: April 3, 2009
Last updated: July 1, 2010
Last verified: April 2009
History of Changes
  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 Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • contrast sensitivity [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876707

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

No publications provided

Responsible Party: Marcony Rodrigues de Santhiago, University of São Paulo
ClinicalTrials.gov Identifier: NCT00876707     History of Changes
Other Study ID Numbers: 0088/09
Study First Received: April 3, 2009
Last Updated: July 1, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 23, 2013