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

U

University of Sao Paulo

Status and phase

Completed
Phase 2
Phase 1

Conditions

Cataract
Astigmatism

Treatments

Device: ReZoom implant
Device: Tecnis implant
Device: ReSTOR implant

Study type

Interventional

Funder types

Other

Identifiers

NCT00876707
0088/09

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No 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

Trial design

60 participants in 3 patient groups

Tecnis
Active Comparator group
Treatment:
Device: Tecnis implant
ReSTOR
Active Comparator group
Treatment:
Device: ReSTOR implant
ReZoom
Active Comparator group
Treatment:
Device: ReZoom implant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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