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

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.

Study Overview

• Status: Unknown
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: Cataract surgery

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Torras, MD; Phone Number: +34 932275667; Email: jtorras@clinic.ub.es

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic. Casa maternitat
    • Principal Investigator: Josep Torras, MD
    • Contact: Josep Torras, MD; Phone Number: +34932275667; Email: jtorras@clinic.ub.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Implantation of difractive multifocal IOL	Procedure: Cataract surgery; Implantation of multifocal or monofocal IOL; Other Names: SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator; SN60WF (Alcon labs, Fotworth, Texas) in sham comparator
Sham Comparator: Implantation of monofocal IOL	Procedure: Cataract surgery; Implantation of multifocal or monofocal IOL; Other Names: SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator; SN60WF (Alcon labs, Fotworth, Texas) in sham comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Principal Investigator: Josep Torras, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimate): March 17, 2010

Study Record Updates

• Last Update Posted (Estimate): March 17, 2010
• Last Update Submitted That Met QC Criteria: March 16, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Diffractive multifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Dipivefrin
• Other Study ID Numbers: ECICOFPALIORES09