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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
  Purpose

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
Presbyopia
 Procedure: Cataract surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088282

Contacts
Contact: Josep Torras, MD +34 932275667 jtorras@clinic.ub.es

Locations
Spain
Hospital Clinic. Casa Maternitat Not yet recruiting
Barcelona, Spain, 08028
Contact: Josep Torras, MD     +34 932275667     jtorras@gmail.com    
Principal Investigator: Josep Torras, MD            
Hospital Clinic. Casa maternitat Not yet recruiting
Barcelona, Spain, 08028
Contact: Josep Torras, MD     +34932275667     jtorras@clinic.ub.es    
Principal Investigator: Josep Torras, MD            
Sponsors and Collaborators
University of Barcelona
Investigators
Principal Investigator: Josep Torras, MD Hospital Clinic. Barcelona.
  More Information

No publications provided

Responsible Party: Josep Torras MD, Hospital Clinic Barcelona
ClinicalTrials.gov Identifier: NCT01088282     History of Changes
Other Study ID Numbers: ECICOFPALIORES09
Study First Received: March 16, 2010
Last Updated: March 16, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Barcelona:
Diffractive multifocal IOL

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013