NCT00762216

Brief Summary

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

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

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 10, 2010

Completed
Last Updated

October 31, 2012

Status Verified

May 1, 2010

Enrollment Period

1.1 years

First QC Date

September 26, 2008

Results QC Date

April 14, 2010

Last Update Submit

October 26, 2012

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

  • Rotational Stability

    Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

    6 Months post-surgery

Secondary Outcomes (1)

  • Residual Refractive Cylinder

    6 Months post-surgery

Study Arms (1)

Toric

OTHER

Implantation with the AcrySof® Toric intraocular lens

Device: AcrySof® Toric intraocular lens

Interventions

AcrySof® Toric intraocular lensDEVICE

Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Toric

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Monolateral or bilateral cataracts
  • anticipated intraocular lens (IOL) power of +10 Diopters (D) \~ +25D
  • \~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
  • able to sign the informed consent, to comply with scheduled visits and other study procedures

You may not qualify if:

  • Preoperative ocular pathology
  • previous intraocular or corneal surgery
  • an increased risk for complications which could require vitreoretinal surgery
  • corneal irregularities
  • corneal opacities
  • current contact lens usage
  • uncontrolled diabetes

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

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
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Last Updated

October 31, 2012

Results First Posted

May 10, 2010

Record last verified: 2010-05

Locations

US(1)