NCT00758550CompletedPhase 4
Visual Function After Bilateral Implantation of AcrySof® Toric
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Uncorrected Visual Acuity (UCVA)
Study Overview
Brief Summary
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral cataracts
- •40~80 years of age
- •4 Days - 1 Week interval between a single patient's surgery
- •dilated pupil size (in dim light) ≥ 4.0 mm
- •Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
- •0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings
Exclusion Criteria
- •Preoperative ocular pathology
- •Previous intraocular or corneal surgery
- •An increased risk for complications which could require vitreoretinal surgery
- •Corneal irregularities
- •Corneal opacities
- •Current contact lens usage(within 6 months prior to first surgery)
Arms & Interventions
AcrySof Toric IOL
Experimental
AcrySof Toric Intraocular Lens (IOL)
Intervention: AcrySof® Toric IOL (Device)
AcrySof Natural IOL
Active Comparator
AcrySof Natural Intraocular Lens (IOL)
Intervention: AcrySof Natural (Device)
Outcomes
Primary Outcomes
Uncorrected Visual Acuity (UCVA)
Time Frame: 6 Months after surgery
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Secondary Outcomes
- Questionnaire Results(6 Months)
Investigators
Study Sites (1)
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