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

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