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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01088282
• Other study ID #: ECICOFPALIORES09
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2010
• Last updated: March 16, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: University of Barcelona
• Contact: Josep Torras, MD
• Phone: +34 932275667
• Email: jtorras[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Procedure:
• Cataract surgery
Implantation of multifocal or monofocal IOL

Locations

Country	Name	City	State
Spain	Hospital Clinic. Casa Maternitat	Barcelona
Spain	Hospital Clinic. Casa maternitat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function quality (VF-14)		At 1 and 3 months post-intervention	No
Secondary	Visual acuity with and without correction		at 1 and 3 months post-intervention	No
Secondary	Determine Expense in glasses		at 3 months post-intervention	No