Low Cylinder Toric

Cataracts Clinical Trial

Official title:

Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732030
• Other study ID #: M07-005
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2008
• Last updated: March 25, 2010
• Start date: June 2007

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Cataracts

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

Exclusion Criteria:

• Preoperative ocular pathology

• Planned monovision

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataracts

Intervention

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

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Residual Refractive Cylinder	Residual Refractive Cylinder at month 6 measured in diopters (D).	6 Month	No
Secondary	Patient Satisfaction Survey	Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.	6 months	No