Presbyopia Clinical Trial
Official title:
Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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