Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Not Applicable
Completed
- Conditions
- Visual Acuity
- Interventions
- Device: RESTOR IOL Model SA60D3
- Registration Number
- NCT00759096
- Lead Sponsor
- Alcon Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Acrysof ReSTOR IOL RESTOR IOL Model SA60D3 AcrySof ReSTOR Intraocular lens (IOL) implanted
- Primary Outcome Measures
Name Time Method Near Uncorrected Visual Acuity(UCVA 6 months after surgery of 2nd eye Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
- Secondary Outcome Measures
Name Time Method Contrast Sensitivity 6 months after sugery of the 2nd eye
Trial Locations
- Locations (1)
Alcon Call Center
🇺🇸Fort Worth, Texas, United States