N/A
N=103
A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT01684007 ↗Enrolled (actual)
103
Serious AEs
1.9%
Results posted
May 2015
Primary outcome: Primary: Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) — 0.13; 0.09 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 ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) |
0.13; 0.09 | — |
| SECONDARY Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) |
0.26; 0.10 | — |
Summary
The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.
Eligibility Criteria
Inclusion Criteria
- Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
- Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
- Willing to have second eye surgery within 45 days of first eye surgery;
- Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
- Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
- Significant irregular corneal astigmatism as demonstrated by corneal topography;
- Severe degenerative visual disorders;
- Previous corneal surgery;
- Amblyopia;
- Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;
- History of corneal disease;
- Severe diabetic retinopathy;
- History of retinal detachment;
- Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
- Pregnant or planning pregnancy during course of study;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01684007). 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.