NCT00732030

Brief Summary

Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
26

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

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2010

Completed
Last Updated

April 7, 2010

Status Verified

March 1, 2010

Enrollment Period

1.8 years

First QC Date

August 7, 2008

Results QC Date

April 29, 2009

Last Update Submit

March 25, 2010

Conditions

Cataracts

Keywords

Toric IOL

Outcome Measures

Primary Outcomes (3)

  • Uncorrected Distance Visual Acuity

    Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

    6 months

  • Best Corrected Distance Visual Acuity

    Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

    6 Months

  • Residual Refractive Cylinder

    Residual Refractive Cylinder at month 6 measured in diopters (D).

    6 Month

Secondary Outcomes (1)

  • Patient Satisfaction Survey

    6 months

Study Arms (1)

AcrySof Toric T3

EXPERIMENTAL

Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL)

Device: Toric IOL (SN60T3)

Interventions

Toric IOL (SN60T3)DEVICE

Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.

AcrySof Toric T3

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Cataracts
  • Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)

You may not qualify if:

  • Preoperative ocular pathology
  • Planned monovision

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

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

June 1, 2007

Primary Completion

March 1, 2009

Last Updated

April 7, 2010

Results First Posted

April 7, 2010

Record last verified: 2010-03

Locations

US(1)