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

Completed

• Conditions: Astigmatism; Cataracts
• Interventions: Device: SN60WF Intraocular Lens; Device: SN6AT6 Intraocular Lens; Device: SN6AT7 Intraocular Lens; Device: SN6AT8 Intraocular Lens; Device: SN6AT9 Intraocular Lens

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Toric High Cylinder Power IOL	SN6AT8 Intraocular Lens	Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Toric High Cylinder Power IOL	SN6AT7 Intraocular Lens	Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Monofocal IOL	SN60WF Intraocular Lens	Monofocal intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Toric High Cylinder Power IOL	SN6AT6 Intraocular Lens	Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.
Toric High Cylinder Power IOL	SN6AT9 Intraocular Lens	Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation.

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