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

July 1, 2010 updated by: University of Sao Paulo

Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ReSTOR
Device: ReSTOR implant
Implant of multifocal IOL ReSTOR
ACTIVE_COMPARATOR: Tecnis
Device: Tecnis implant
Implant of diffractive multifocal IOL Tecnis
ACTIVE_COMPARATOR: ReZoom
Device: ReZoom implant
Implant of multifocal IOL ReZoom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual acuity, wavefront data and modulation transfer function
Time Frame: 30, 90 and 120 days after surgery
30, 90 and 120 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
contrast sensitivity
Time Frame: 90 days after surgery
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (ESTIMATE)

April 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0088/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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