N/A
N=25
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01257217 ↗Enrolled (actual)
25
Serious AEs
6.7%
Results posted
Apr 2017
Primary outcome: Primary: Mean Binocular Defocus VA at Month 3 — 0.78; 0.59; 0.65; 0.45 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 (Device); AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT (Device); Acri.LISA® 366D IOL (Device); Acri.LISA® 466TD Toric IOL (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Defocus VA at Month 3 |
0.78; 0.59; 0.65; 0.45; 0.58; 0.29 | — |
| SECONDARY Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 |
-0.02; -0.05; 0.39; 0.35; 0.33; 0.35 | — |
| SECONDARY Uncorrected Visual Acuity Across a Range of Distances at Month 3 |
0.14; 0.03; 0.37; 0.27; 0.36; 0.33 | — |
| SECONDARY Mean Refractive Spherical Equivalent at Month 3 |
0.1; -0.3 | — |
| SECONDARY Mean Radner Reading Speed |
90.60; 90.46; 109.7; 113.2 | — |
| SECONDARY Patient Reported Outcomes at Month 3 |
1.78; 1.48; 1.13; 1.19; 1.32; 1.00 | — |
Summary
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Sign informed consent;
- Able to attend postoperative examinations per protocol schedule;
- Diagnosed with bilateral cataracts;
- Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- Preoperative astigmatism ≤ 2.5 diopter;
- Good ocular health, with the exception of cataracts;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- Able to undergo second eye surgery within one month of the first eye surgery;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Any ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Diabetic retinopathy;
- Macular degeneration;
- History of retinal detachment;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01257217). 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.