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

Alcon

Status: Completed

Conditions: Astigmatism; Cataracts

Treatments: Device: SN60WF Intraocular Lens; Device: SN6AT7 Intraocular Lens; Device: SN6AT9 Intraocular Lens; Device: SN6AT8 Intraocular Lens; Device: SN6AT6 Intraocular Lens

Study type: Observational

Funder types: Industry

Identifiers

NCT01601665

C-11-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 477 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

477 participants in 2 patient groups

Toric High Cylinder Power IOL

Description:

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.

Treatment:

Device: SN6AT6 Intraocular Lens

Device: SN6AT8 Intraocular Lens

Device: SN6AT9 Intraocular Lens

Device: SN6AT7 Intraocular Lens

Monofocal IOL

Description:

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.

Treatment:

Device: SN60WF Intraocular Lens