A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses
This study has been completed.
Information provided by (Responsible Party):
First received: February 17, 2011
Last updated: October 22, 2012
Last verified: October 2011
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).
Device: ReSTOR +3
Device: LENTIS MPlus
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
Primary Outcome Measures:
- Unilateral Uncorrected Near Visual Acuity [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
| Study Start Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
Experimental: ReSTOR +3
Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1
Device: ReSTOR +3
Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
Active Comparator: LENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model
Device: LENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01299155
|Contact Alcon Call Center for Trial Locations
|Oviedo, Asturias, Spain, 33012 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 17, 2011
||October 22, 2012
||Spain: Comité Ético de Investigación Clínica
Keywords provided by Alcon Research:
ClinicalTrials.gov processed this record on March 01, 2015
Presbyopia Correcting IOL