A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)

Alcon Research1 site in 1 country24 target enrollmentMarch 2011

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Alcon Research
Enrollment: 24
Locations: 1
Primary Endpoint: Unilateral Uncorrected Near Visual Acuity
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

September 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

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