NCT00818116CompletedPhase 4
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Study Overview
Brief Summary
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
- •50~75 years of age
- •<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion Criteria
- •Patients with pre-existing conditions that could skew the results.
- •Any of conditions before and during surgery specified in the product information.
Outcomes
Primary Outcomes
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
Time Frame: 6 Months Following Cataract Surgery
Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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