N/A
N=320
Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT01510717 ↗Enrolled (actual)
320
Serious AEs
3.6%
Results posted
May 2015
Primary outcome: Primary: Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 — 0.322; 0.512 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] (Device); AcrySof® IQ Monofocal IOL Model SN60WF (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 |
0.322; 0.512 | — |
| PRIMARY Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 |
4; 0; 0; 0; 0; 0 | — |
| PRIMARY Photopic Contrast Sensitivity Without Glare at Day 120-180 |
1.676; 1.743; 1.816; 1.938; 1.460; 1.555 | — |
| PRIMARY Photopic Contrast Sensitivity With Glare at Day 120-180 |
1.608; 1.692; 1.684; 1.844; 1.334; 1.475 | — |
| PRIMARY Mesopic Contrast Sensitivity Without Glare at Day 120-180 |
1.594; 1.622; 1.563; 1.618; 1.581; 1.673 | — |
| PRIMARY Mesopic Contrast Sensitivity With Glare at Day 120-180 |
1.536; 1.596; 1.542; 1.600; 1.543; 1.617 | — |
| SECONDARY Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 |
0.025; 0.003 | — |
| SECONDARY Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 |
0.426; 0.632 | — |
| SECONDARY Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 |
35; 33; 104; 109; 12; 13 | — |
| SECONDARY Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 |
25; 19; 70; 53; 34; 40 | — |
Summary
The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bilateral cataracts
- Willing and able to complete all required postoperative visits
- Calculated lens power within the available supply range
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
- Preoperative astigmatism less than 1.0 diopter
- Clear intraocular media other than cataract in study eyes
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
- Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Previous refractive surgery
- Inflammation or edema of the cornea
- Optic nerve atrophy
- Pregnancy
- Current participation in another investigational drug or device study
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01510717). 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.