ReSTOR Natural +3.0D (Diopter) Study In Japan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Uncorrected Intermediate Visual Acuity
Study Overview
Brief Summary
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Planned bilateral cataract removal by phacoemulsification
- •Potential postoperative best corrected visual acuity of 0.5 or over
- •1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry
Exclusion Criteria
- •Poorly controlled glaucoma
- •Progressive diabetic retinopathy
Arms & Interventions
SN6AD1
AcrySof ReSTOR Model SN6AD1 Intraocular Lens
Intervention: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 (Device)
Outcomes
Primary Outcomes
Uncorrected Intermediate Visual Acuity
Time Frame: 1 year after surgery
Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Distance Visual Acuity
Time Frame: 1 year after surgery
Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Near Visual Acuity
Time Frame: 1 year after surgery
Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Secondary Outcomes
No secondary outcomes reported