Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | July 2015 |
Post Approval Study of the AcrySof® IQ Toric High Cylinder Power 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.
lenses in a larger population in clinical practice and assure the continued safety of these
approved devices.
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.
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.
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.
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