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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01299155
Collaborator
(none)
24
1
2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: ReSTOR +3
  • Device: LENTIS MPlus
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Unilateral Uncorrected Near Visual Acuity [3 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Contact Alcon Call Center for Trial Locations Oviedo Asturias Spain 33012

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01299155
Other Study ID Numbers:
  • M10-070
First Posted:
Feb 18, 2011
Last Update Posted:
Oct 23, 2012
Last Verified:
Oct 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2012