Cataract
Conditions
Keywords
Intraocular Lens, Presbyopia Correcting IOL
Brief summary
To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).
Interventions
DEVICEReSTOR +3
Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
DEVICELENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* are willing and able to understand and sign an informed consent * \<= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure regular astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements. * are willing and able to attend postoperative examinations per protocol schedule * are more than 21 years of age, of either gender and any race: * require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure * be willing to have second eye surgery within one month of first eye surgery * are in good ocular health, with the exception of cataracts * are free of disease(s)/condition(s) listed in the Precautions section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts * are able to read and understand one of the following languages: Dutch or Spanish
Exclusion criteria
* Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery * An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.) * Previous corneal surgery and/or reshaping * Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy) * History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.) * History of retinal detachment * Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness). * suturing of incision required at time of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unilateral Uncorrected Near Visual Acuity | 3 months after surgery |
Countries
Spain
Outcome results
None listed