NCT00876707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 2, 2010

Status Verified

April 1, 2009

Enrollment Period

8 months

First QC Date

April 3, 2009

Last Update Submit

July 1, 2010

Conditions

CataractAstigmatism

Keywords

wavefrontmultifocal IOLmodulation transfer functionintraocular lenseswavefront dataVisual performance

Outcome Measures

Primary Outcomes (1)

  • visual acuity, wavefront data and modulation transfer function

    30, 90 and 120 days after surgery

Secondary Outcomes (1)

  • contrast sensitivity

    90 days after surgery

Study Arms (3)

Tecnis

ACTIVE COMPARATOR
Device: Tecnis implant

ReSTOR

ACTIVE COMPARATOR
Device: ReSTOR implant

ReZoom

ACTIVE COMPARATOR
Device: ReZoom implant

Interventions

Tecnis implantDEVICE

Implant of diffractive multifocal IOL Tecnis

Tecnis
ReSTOR implantDEVICE

Implant of multifocal IOL ReSTOR

ReSTOR
ReZoom implantDEVICE

Implant of multifocal IOL ReZoom

ReZoom

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 2, 2010

Record last verified: 2009-04

Locations

BR(1)