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CompletedNCT00876707IOLUpdated Jul 2, 2010

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

A Phase 1/2 interventional study of Tecnis implant and ReSTOR implant in Cataract and Astigmatism, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-07-02.

Sponsored by University of Sao Paulo · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
  • Astigmatism

Keywords

  • wavefront
  • multifocal IOL
  • modulation transfer function
  • intraocular lenses
  • wavefront data
  • Visual performance
03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 1,171 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Tecnis

    Device: Tecnis implant

  • Active comparator
    ReSTOR

    Device: ReSTOR implant

  • Active comparator
    ReZoom

    Device: ReZoom implant

Interventions

  • DeviceTecnis implant

    Implant of diffractive multifocal IOL Tecnis

  • DeviceReSTOR implant

    Implant of multifocal IOL ReSTOR

  • DeviceReZoom implant

    Implant of multifocal IOL ReZoom

06

What researchers measure

Primary outcomes

  1. visual acuity, wavefront data and modulation transfer function

    Time frame: 30, 90 and 120 days after surgery

Secondary outcomes

  1. contrast sensitivity

    Time frame: 90 days after surgery

07

Study locations

1 site
  • University of São Paulo
    São Paulo, São Paulo 05403-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00876707
First posted
Apr 7, 2009
Start date
Mar 2009
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Jul 2, 2010
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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