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

Primary Purpose

Cataract, Astigmatism

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Tecnis implant
ReSTOR implant
ReZoom implant
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tecnis

ReSTOR

ReZoom

Arm Description

Outcomes

Primary Outcome Measures

visual acuity, wavefront data and modulation transfer function

Secondary Outcome Measures

contrast sensitivity

Full Information

First Posted
April 3, 2009
Last Updated
July 1, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00876707
Brief Title
Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses
Acronym
IOL
Official Title
Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
Keywords
wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tecnis
Arm Type
Active Comparator
Arm Title
ReSTOR
Arm Type
Active Comparator
Arm Title
ReZoom
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tecnis implant
Intervention Description
Implant of diffractive multifocal IOL Tecnis
Intervention Type
Device
Intervention Name(s)
ReSTOR implant
Intervention Description
Implant of multifocal IOL ReSTOR
Intervention Type
Device
Intervention Name(s)
ReZoom implant
Intervention Description
Implant of multifocal IOL ReZoom
Primary Outcome Measure Information:
Title
visual acuity, wavefront data and modulation transfer function
Time Frame
30, 90 and 120 days after surgery
Secondary Outcome Measure Information:
Title
contrast sensitivity
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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

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