Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9

Completed

• Conditions: Astigmatism; Cataracts

• Registration Number: NCT01601665
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

Detailed Description

In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

• Diagnosed with bilateral cataracts and in the targeted astigmatism range.
• Planned cataract removal by phacoemulsification.
• Pupil size greater than or equal to 6 mm after dilation.
• Able to undergo second eye surgery within 30 days of first eye surgery.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Irregular corneal astigmatism.
• Any inflammation or swelling of the cornea.
• Any corneal abnormality other than regular corneal astigmatism.
• Previous corneal refractive surgery.
• Amblyopia.
• Diabetic retinopathy.
• Uncontrolled glaucoma.
• Currently participating in another investigational drug or device study that may confound the results of this investigation.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Severe Visual Distortions	6 months	As assessed by a Patient Reported Outcomes (PRO) questionnaire. Subjects will be categorized as experiencing a severe visual distortion if they indicate "severe" as a response to any of the three visual distortion-related questions on the questionnaire.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States