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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: ReSTOR +3; Device: LENTIS MPlus

• Registration Number: NCT01299155
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Study Start: 2011-03
• Primary Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReSTOR +3	ReSTOR +3	Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1
LENTIS MPlus	LENTIS MPlus	Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model

Primary Outcome Measures

Name	Time	Method
Unilateral Uncorrected Near Visual Acuity	3 months after surgery

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇪🇸 Oviedo, Asturias, Spain