NCT01088282

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Cataract surgery	Implantation of multifocal or monofocal IOL

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2010-03-17
• Last updated: 2010-03-17

Locations

2 sites across 1 country: Spain