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Completed

NCT Number: NCT01601665

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

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.

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Key information

Conditions

Cataracts Astigmatism Cataract Eye Diseases Lens Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SN6AT6 Intraocular Lens

Device

Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.

Other names: AcrySof® IQ Toric Model SN6AT6

SN6AT7 Intraocular Lens

Device

Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.

Other names: AcrySof® IQ Toric Model SN6AT7

SN6AT8 Intraocular Lens

Device

Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.

Other names: AcrySof® IQ Toric Model SN6AT8

SN6AT9 Intraocular Lens

Device

Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.

Other names: AcrySof® IQ Toric Model SN6AT9

SN60WF Intraocular Lens

Device

Acrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.

Other names: AcrySof® IQ Aspheric NATURAL Model SN60WF

Primary outcomes

  1. Rate of Severe Visual Distortions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 18, 2012
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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