NCT01215045

Brief Summary

Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

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

June 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
Last Updated

October 5, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

August 12, 2008

Last Update Submit

October 4, 2010

Conditions

Cataract

Keywords

AcrySof ReSTOR Aspheric +4

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    6 months

Secondary Outcomes (1)

  • Contrast sensitivity, patient survey

    6 months

Study Arms (1)

ReSTOR +4

AcrySof ReSTOR Aspheric +4

Device: AcrySof ReSTOR Aspheric +4

Interventions

AcrySof ReSTOR Aspheric +4DEVICE

Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)

ReSTOR +4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants taken from physician's patient pool implanted with the AcrySof ReSTOR +4 Intraocular Lens (IOL)

You may qualify if:

  • Diagnosed with cataracts

You may not qualify if:

  • Preexisting conditions confounding results; \> 1 Diopter preoperative astigmatism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2008

First Posted

October 5, 2010

Study Start

June 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 5, 2010

Record last verified: 2010-10

Locations

US(1)