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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299155
• Other study ID #: M10-070
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: October 22, 2012
• Start date: March 2011

Study information

• Verified date: October 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• ReSTOR +3
Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
• LENTIS MPlus
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.

Locations

Country	Name	City	State
Spain	Contact Alcon Call Center for Trial Locations	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unilateral Uncorrected Near Visual Acuity		3 months after surgery	No