NCT00760058

Brief Summary

The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 12, 2015

Status Verified

March 1, 2010

Enrollment Period

2.5 years

First QC Date

September 24, 2008

Last Update Submit

May 8, 2015

Conditions

Cataract

Keywords

cataract, intraocular lens

Outcome Measures

Primary Outcomes (1)

  • Contrast sensitivity

    3 months

Secondary Outcomes (1)

  • Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.

    3 months

Study Arms (3)

1

EXPERIMENTAL

AcrySof® IQ intraocular lens

Device: AcrySof® IQ IOL

2

ACTIVE COMPARATOR

Tecnis® Aspheric intraocular lens

Device: Tecnis® Aspheric intraocular lens

3

ACTIVE COMPARATOR

Akreos® MI60 intraocular lens

Device: Akreos® MI60 intraocular lens

Interventions

AcrySof® IQ IOLDEVICE

Replacement of natural crystalline lens in cataract surgery

1
Tecnis® Aspheric intraocular lensDEVICE

Replacement of natural crystalline lens in cataract surgery

2
Akreos® MI60 intraocular lensDEVICE

Replacement of natural crystalline lens in cataract surgery

3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, aged 50 and over.
  • Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
  • Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
  • Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
  • Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

You may not qualify if:

  • Subjects who have previously had corneal surgery.
  • Subjects who have potential visual acuity which is \< 6/12 due to other ocular pathology
  • Subjects with corneal pathology.
  • Subjects with astigmatism of greater than 1D.
  • Subjects diagnosed with glaucoma.
  • Subjects diagnosed with diabetes.
  • Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
  • Subjects with a know history of poor compliance
  • Subjects with planned adjunctive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 12, 2015

Record last verified: 2010-03

Locations

US(1)