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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University of Barcelona.
Recruitment status was:  Not yet recruiting
Information provided by:
University of Barcelona Identifier:
First received: March 16, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

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 Intervention
Procedure: Cataract surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Barcelona:

Primary Outcome Measures:
  • Visual function quality (VF-14) [ Time Frame: At 1 and 3 months post-intervention ]

Secondary Outcome Measures:
  • Visual acuity with and without correction [ Time Frame: at 1 and 3 months post-intervention ]
  • Determine Expense in glasses [ Time Frame: at 3 months post-intervention ]

Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01088282

Hospital Clinic. Casa Maternitat
Barcelona, Spain, 08028
Sponsors and Collaborators
University of Barcelona
Principal Investigator: Josep Torras, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Josep Torras MD, Hospital Clinic Barcelona Identifier: NCT01088282     History of Changes
Other Study ID Numbers: ECICOFPALIORES09 
Study First Received: March 16, 2010
Last Updated: March 16, 2010

Keywords provided by University of Barcelona:
Diffractive multifocal IOL

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on February 20, 2017