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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601665
• Other study ID #: C-11-020
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: August 3, 2015
• Start date: February 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astigmatism
• Cataracts

Intervention

Device:
• SN6AT6 Intraocular Lens
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.
• SN6AT7 Intraocular Lens
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.
• SN6AT8 Intraocular Lens
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.
• SN6AT9 Intraocular Lens
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.
• SN60WF Intraocular Lens
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.

Locations

Country	Name	City	State
United States	Contact 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	Rate of Severe Visual Distortions	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.	6 months	Yes