A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses

Alcon

Status

Completed

Conditions

Cataract

Treatments

Device: LENTIS MPlus

Device: ReSTOR +3

Study type

Interventional

Funder types

Industry

Identifiers

NCT01299155

M10-070

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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