NCT00818116

Brief Summary

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

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

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 30, 2010

Completed
Last Updated

July 30, 2010

Status Verified

June 1, 2010

Enrollment Period

7 months

First QC Date

January 6, 2009

Results QC Date

June 30, 2010

Last Update Submit

June 30, 2010

Conditions

Cataracts

Keywords

Cataractvisual acuityAcrySof ReSTOR Aspheric Intraoculare LensBilateral cataract

Outcome Measures

Primary Outcomes (1)

  • Uncorrected and Best Corrected Visual Acuities (Near and Distance)

    Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

    6 Months Following Cataract Surgery

Study Arms (1)

ReSTOR Aspheric IOL

EXPERIMENTAL

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)

Device: AcrySof ReSTOR Aspheric IOL

Interventions

AcrySof ReSTOR Aspheric IOLDEVICE

Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

ReSTOR Aspheric IOL

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
  • \~75 years of age
  • \<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

You may not qualify if:

  • Patients with pre-existing conditions that could skew the results.
  • Any of conditions before and during surgery specified in the product information.

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
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Last Updated

July 30, 2010

Results First Posted

July 30, 2010

Record last verified: 2010-06

Locations

US(1)