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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Barcelona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Barcelona
ClinicalTrials.gov Identifier:
NCT01088282
First received: March 16, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

March 16, 2010
March 16, 2010
March 2010
December 2010   (final data collection date for primary outcome measure)
Visual function quality (VF-14) [ Time Frame: At 1 and 3 months post-intervention ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Visual acuity with and without correction [ Time Frame: at 1 and 3 months post-intervention ] [ Designated as safety issue: No ]
  • Determine Expense in glasses [ Time Frame: at 3 months post-intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain
Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Presbyopia
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
  • Active Comparator: Implantation of difractive multifocal IOL
    Intervention: Procedure: Cataract surgery
  • Sham Comparator: Implantation of monofocal IOL
    Intervention: Procedure: Cataract surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
March 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Josep Torras, MD +34 932275667 jtorras@clinic.ub.es
Spain
 
NCT01088282
ECICOFPALIORES09
No
Josep Torras MD, Hospital Clinic Barcelona
University of Barcelona
Not Provided
Principal Investigator: Josep Torras, MD Hospital Clinic of Barcelona
University of Barcelona
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP