N/A
N=30
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT00759096 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Near Uncorrected Visual Acuity(UCVA — 0.5 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RESTOR IOL Model SA60D3 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Near Uncorrected Visual Acuity(UCVA |
0.5 | — |
| SECONDARY Contrast Sensitivity |
— | — |
Summary
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
Eligibility Criteria
Inclusion Criteria
- ≥21 years of either gender or any race
- Potential post-op VA 20/20
- Pre-op astigmatism ≤ 1.0D
- Able to sign the informed consent
- Able to complete all required postoperative visits
- Planned cataract removal by phaco
- Clear intraocular media other than cataract
Exclusion Criteria
- Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
- Any corneal pathology and previous corneal refractive surgery
- Patients with unrealistic expectations in anticipated post-op VA
- Happy to wear glasses
- Occupational night driver
Data sourced from ClinicalTrials.gov (NCT00759096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.