NCT01214863

Brief Summary

This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 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

August 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
Last Updated

October 1, 2012

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

August 7, 2008

Last Update Submit

September 27, 2012

Conditions

CataractsAstigmatism

Keywords

Toric Intraocular Lens (IOL)

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    1 day to 6 months

Secondary Outcomes (1)

  • Postoperative refractive cylinder

    1day to 6 months

Study Arms (3)

T3

Model SN60T3 assigned by AcrySof Toric calculator

Device: T3

T4

Model SN60T4 assigned by AcrySof Toric calculator

Device: T4

T5

Model SN60T5 assigned by AcrySof Toric calculator

Device: T5

Interventions

T3DEVICE

Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3

T3
T4DEVICE

Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4

T4
T5DEVICE

Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5

T5

Eligibility Criteria

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

Study population chosen from physician's patients implanted with the AcrySof Toric intraocular lens (IOL)

You may qualify if:

  • Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator

You may not qualify if:

  • Ocular comorbidities affecting visual outcome data,
  • Prior refractive surgery,
  • Irregular astigmatism

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

Related Publications (1)

  • Holladay JT, Wilcox RR, Koch DD, Wang L. Astigmatism analysis and reporting of surgically induced astigmatism and prediction error. J Cataract Refract Surg. 2022 Jul 1;48(7):799-812. doi: 10.1097/j.jcrs.0000000000000871.

    PMID: 35749069DERIVED

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Design

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

Study Record Dates

First Submitted

August 7, 2008

First Posted

October 5, 2010

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Last Updated

October 1, 2012

Record last verified: 2010-10

Locations

US(1)