N/A
N=208
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01290068 ↗Enrolled (actual)
208
Serious AEs
10.7%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants Classified as Responders — 45.7; 2.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL (Device); AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL (Device); Monofocal IOL (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Classified as Responders |
45.7; 2.1 | — |
| PRIMARY Proportion of Participants Reporting Spectacle Independence at All Distances |
73.3; 25.3 | — |
| PRIMARY Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions) |
87.63; 83.57; 95.19; 94.85; 83.67; 46.34 | — |
| SECONDARY Median Total Spectacle Cost Prior to Any Reimbursement |
0.00; 85.729 | — |
Summary
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
Eligibility Criteria
Inclusion Criteria
- Willing and able to understand and sign an Informed Consent;
- Willing and able to attend post-operative examinations as per protocol schedule;
- Diagnosis of bilateral, age-related cataracts;
- Planned cataract removal via phacoemulsification with implantation of an IOL;
- Available to undergo second eye surgery within 6 weeks of the first eye surgery;
- Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
- No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
- Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
- Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Previous corneal surgery and/or reshaping;
- Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
- Pregnant, lactating, or planning pregnancy during the course of study;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01290068). 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.