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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 29, 2014