Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- Uncorrected Visual Acuity (UCVA)
Study Overview
Brief Summary
A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosed with cataracts
Exclusion Criteria
- •Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
- •<1 diopter astigmatism by keratometry readings.
Arms & Interventions
ReSTOR Aspheric +3
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Intervention: ReSTOR (Device)
Outcomes
Primary Outcomes
Uncorrected Visual Acuity (UCVA)
Time Frame: 6 months
Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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