NCT00733512

Brief Summary

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 15, 2010

Completed
Last Updated

March 27, 2017

Status Verified

April 1, 2010

Enrollment Period

9 months

First QC Date

August 8, 2008

Results QC Date

March 24, 2010

Last Update Submit

February 23, 2017

Conditions

Cataract

Keywords

ReSTOR Aspheric +4 IOL

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

    1 week to 10 months

Secondary Outcomes (1)

  • Contrast Sensitivity

    1 week to 10 months

Study Arms (1)

ReSTOR

AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)

Device: ReSTOR

Interventions

ReSTORDEVICE

Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.

ReSTOR

Eligibility Criteria

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

Subjects were selected from primary care clinics.

You may qualify if:

  • operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

You may not qualify if:

  • ocular comorbidities confounding study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 13, 2008

Study Start

June 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 27, 2017

Results First Posted

April 15, 2010

Record last verified: 2010-04

Locations

US(1)