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

Phase 1

Completed

• Conditions: Cataract; Astigmatism
• Interventions: Device: Tecnis implant; Device: ReSTOR implant; Device: ReZoom implant

• Registration Number: NCT00876707
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tecnis	Tecnis implant	-
ReSTOR	ReSTOR implant	-
ReZoom	ReZoom implant	-

Primary Outcome Measures

Name	Time	Method
visual acuity, wavefront data and modulation transfer function	30, 90 and 120 days after surgery

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity	90 days after surgery

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil