This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: April 3, 2009
Last updated: July 1, 2010
Last verified: April 2009
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


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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
  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 identifier: NCT00876707

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 Identifier: NCT00876707     History of Changes
Other Study ID Numbers: 0088/09
Study First Received: April 3, 2009
Last Updated: July 1, 2010

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

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Refractive Errors processed this record on August 23, 2017