Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric
Phase 4
Withdrawn
- Conditions
- Cataract
- Interventions
- Device: AcrySof® Toric IOL
- Registration Number
- NCT00761488
- Lead Sponsor
- Alcon Research
- Brief Summary
To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.
Exclusion Criteria
- Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AcrySof® Toric IOL AcrySof® Toric IOL
- Primary Outcome Measures
Name Time Method Corneal astigmatism; IOL rotation Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
- Secondary Outcome Measures
Name Time Method Uncorrected and best distance corrected visual acuities (UCVA and BDCVA) Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.
Trial Locations
- Locations (1)
Alcon Call Center
🇺🇸Fort Worth, Texas, United States