Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 477
- Locations
- 1
- Primary Endpoint
- Rate of Severe Visual Distortions
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported