Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- Best Corrected Decimal VA (5 m)
Study Overview
Brief Summary
The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.
Detailed Description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- 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
- •Sign informed consent;
- •Diagnosed with bilateral cataracts;
- •Planned cataract removal by phacoemulsification;
- •Potential postoperative visual acuity of 0.5 decimal or better in both eyes;
- •Preoperative astigmatism ≤ 1.5 diopter;
- •Clear intraocular media other than cataract in study eyes;
- •Calculated lens power within the available range;
- •Able to undergo second eye surgery within 30 days of the first eye surgery;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Significant irregular corneal aberration as demonstrated by corneal topography;
- •Any inflammation or edema (swelling) of the cornea;
- •Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal;
- •Diabetic retinopathy;
- •Previous refractive surgery, retinal detachment, corneal transplant;
- •Glaucoma;
- •Pregnancy;
- •Currently participating in another investigational drug or device study;
- •Exclusion criteria during surgery;
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Best Corrected Decimal VA (5 m)
Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Uncorrected Decimal VA (5 m)
Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Uncorrected Decimal VA (50 cm)
Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Best Corrected Decimal VA (50 cm)
Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Distance-Corrected Decimal VA (50 cm)
Time Frame: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Secondary Outcomes
- Uncorrected Decimal VA (1 m)(Day 120-180, Day 330-420)
- Mean Best Distance (cm) for Distance Corrected Decimal Near VA(Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420)
- Mean Best Distance (cm) for Uncorrected Decimal Near VA(Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420)
- Percentage of Participants With Positive Response, Stereoscopic Vision Test(Day 120-180 from second eye implantation)
- Distance Corrected Decimal VA (40 cm)(Day 120-180, Day 330-420)
- Best Corrected Far (3 m) Contrast Sensitivity(Day 120-180 from second eye implantation)
- Percentage of Participants With Positive Response, Quality of Life Questions(Day 120-180 from second eye implantation)
- Distance Corrected Decimal VA (1 m)(Day 120-180, Day 330-420)
- Uncorrected Decimal VA (40 cm)(Day 120-180, Day 330-420)
- Uncorrected Decimal VA at Best Distance(Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420)
- Best Corrected Near (46 cm) Contrast Sensitivity(Day 120-180 from second eye implantation)
- Mean Defocus Decimal VA (5 m)(Day 120-180 from second eye implantation)