Astigmatism, Cataracts
Conditions
Keywords
Intraocular lens, Cataracts, Astigmatism, Toric
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.
Interventions
DEVICESN6AT6 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.
DEVICESN6AT7 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.
DEVICESN6AT8 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.
DEVICESN6AT9 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.
DEVICESN60WF 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.
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Visual Distortions | 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. |
Countries
United States
Outcome results
None listed