NCT01045733
Completed
Not Applicable
A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Alcon Research
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Corneal Aberration
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ocular criteria must be met in both eyes.
- •Willing and able to understand and sign an informed consent;
- •Willing and able to attend postoperative examinations per protocol schedule;
- •Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
- •Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
- •Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
- •Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Previous corneal surgery;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Ocular disease and/or condition that may compromise study results;
- •Pregnant or planning pregnancy during course of study;
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Corneal Aberration
Time Frame: Month 6 postoperative
Secondary Outcomes
- Visual Acuity(Month 6 postoperative)
- Corneal Cylinder(6 months)
Study Sites (1)
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