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

NCT01088282 | Unknown

• 1 other identifier: ECICOFPALIORES09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Presbyopia

Keywords

Diffractive multifocal IOL

Outcome Measures

Primary Outcomes (1)

• Visual function quality (VF-14)

  At 1 and 3 months post-intervention

Secondary Outcomes (2)

• Visual acuity with and without correction

  at 1 and 3 months post-intervention

• Determine Expense in glasses

  at 3 months post-intervention

Study Arms (2)

Implantation of difractive multifocal IOL

ACTIVE COMPARATOR

Procedure: Cataract surgery

Implantation of monofocal IOL

SHAM COMPARATOR

Procedure: Cataract surgery

Interventions

Cataract surgery PROCEDURE

Implantation of multifocal or monofocal IOL

Also known as: SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator, SN60WF (Alcon labs, Fotworth, Texas) in sham comparator

Implantation of difractive multifocal IOL; Implantation of monofocal IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (2)

Hospital Clinic. Casa Maternitat

Barcelona, Barcelona, 08028, Spain

Location

Hospital Clinic. Casa maternitat

Barcelona, Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Josep Torras, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Torras, MD

CONTACT

+34 932275667; jtorras@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 17, 2010

Record last verified: 2010-02

Locations

ES (2)