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

NCT ID: NCT01088282

Last Updated: 2010-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implantation of difractive multifocal IOL

Group Type: ACTIVE_COMPARATOR

Cataract surgery

Intervention Type: PROCEDURE

Implantation of multifocal or monofocal IOL

Implantation of monofocal IOL

Group Type: SHAM_COMPARATOR

Cataract surgery

Intervention Type: PROCEDURE

Implantation of multifocal or monofocal IOL

Interventions

Cataract surgery

Implantation of multifocal or monofocal IOL

Intervention Type: PROCEDURE

Other Intervention Names

SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator; SN60WF (Alcon labs, Fotworth, Texas) in sham comparator

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Hospital Clinic Barcelona

Principal Investigators

Josep Torras, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic. Casa Maternitat

Barcelona, Barcelona, Spain

Hospital Clinic. Casa maternitat

Barcelona, Barcelona, Spain

Countries

Spain

Central Contacts

Josep Torras, MD

Role: CONTACT

jtorras@clinic.ub.es

+34 932275667

Facility Contacts

Josep Torras, MD

Role: primary

jtorras@gmail.com

+34 932275667

Josep Torras, MD

Role: primary

jtorras@clinic.ub.es

+34932275667

Other Identifiers

ECICOFPALIORES09

Identifier Type: -

Identifier Source: org_study_id