Clinical trial NCT01299155: A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses
Official title: A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular Lens
Presbyopia Correcting IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Unilateral Uncorrected Near Visual Acuity
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Contact Alcon Call Center for Trial Locations
state: Asturias
Study officials:
References: