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OpenTrials
Completed

NCT Number: NCT00876707

Wavefront Analyzes and Visual Performance of 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.

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Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of São Paulo

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tecnis implant

Device

Implant of diffractive multifocal IOL Tecnis

ReSTOR implant

Device

Implant of multifocal IOL ReSTOR

ReZoom implant

Device

Implant of multifocal IOL ReZoom

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: IOL

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2009
Registry last updated
Jul 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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