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Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain

Sponsor
University of Barcelona (Other)
Overall Status
Unknown status
CT.gov ID
NCT01088282
Collaborator
(none)
120
Enrollment
2
Locations
2
Arms
12
Duration (Months)
60
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Surgical correction of presbyopia is possible via the implantation of multifocal intraocular lenses after removal of the crystalline lens. The cost of these implants is approximately 6 times higher than the conventional monofocal implants routinely used in all crystalline surgery for correction of the resulting ametropia. Spectacles for correcting presbyopia, which are necessary after the insertion of monofocal implants, may also have a significant cost.

The proposed trial will involve two randomized groups of patients in need of crystalline/cataract surgery, with monofocal or multifocal lens implants (the same type of lens in both eyes) leaving them emmetropic for distant vision.

The objective is to corroborate with blind-evaluation the effectiveness of multifocal lens implants in obviating the need for glasses to correct presbyopia, to evaluate the benefits of this type of implant, both in global economic terms (adding the cost of the implants to that of corrective glasses where necessary) and in terms of the improved quality of life of the patients, and to confirm the absence of adverse effects.

Findings will be subjected to a statistical quantification.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cataract surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2010
Anticipated Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Implantation of difractive multifocal IOL

Procedure: Cataract surgery
Implantation of multifocal or monofocal IOL
Other Names:
  • SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator
  • SN60WF (Alcon labs, Fotworth, Texas) in sham comparator

    		•
    Sham Comparator: Implantation of monofocal IOL

    Procedure: Cataract surgery
    Implantation of multifocal or monofocal IOL
    Other Names:
  • SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator
  • SN60WF (Alcon labs, Fotworth, Texas) in sham comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual function quality (VF-14) [At 1 and 3 months post-intervention]

    Secondary Outcome Measures

    1. Visual acuity with and without correction [at 1 and 3 months post-intervention]

    2. Determine Expense in glasses [at 3 months post-intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients of both sexes aged 50 and over, with fully-established presbyopia, requiring phacoemulsification + IOL as the surgical technique for the removal of their cataracts.

    • Their capsular bags should be stable, with keratometric astigmatism equal to or lower than 1 diopter.

    • Biometric calculations should indicate an IOL for emmetropy within the common dioptric range for both lenses, i.e. between +6 y +34.

    Exclusion Criteria:

    • Previous corneal refractive surgery

    • Maculopathy, amblyopia or other eye conditions that limit visual power

    • Occupations requiring special driving licenses

    • Keratometric astigmatism higher than 1 diopter

    • Any intraoperative posterior capsular rupture or extracapsular reconversion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinic. Casa Maternitat Barcelona Spain 08028
    2 Hospital Clinic. Casa maternitat Barcelona Spain 08028

    Sponsors and Collaborators

    • University of Barcelona

    Investigators

    • Principal Investigator: Josep Torras, MD, Hospital Clinic of Barcelona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01088282
    Other Study ID Numbers:
    • ECICOFPALIORES09
    First Posted:
    Mar 17, 2010
    Last Update Posted:
    Mar 17, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Diffractive multifocal IOL
    Additional relevant MeSH terms:
    Presbyopia
    Dipivefrin

    Study Results

    No Results Posted as of Mar 17, 2010