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

Study Overview
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Brief Summary
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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.

Official Title
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Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants

Conditions
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Presbyopia

Intervention / Treatment
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* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implantation of difractive multifocal IOL<br> | Procedure: Cataract surgery<br>* Implantation of multifocal or monofocal IOL<br>* Other names: SN60WF (Alcon labs, Fotworth, Texas) in sham comparator;|
| Sham Comparator: Implantation of monofocal IOL<br> | Procedure: Cataract surgery<br>* Implantation of multifocal or monofocal IOL<br>* Other names: SN60WF (Alcon labs, Fotworth, Texas) in sham comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function quality (VF-14) |  | At 1 and 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity with and without correction |  | at 1 and 3 months post-intervention | 
| Determine Expense in glasses |  | at 3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffractive multifocal IOL