Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain
Primary Purpose
Presbyopia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Diffractive multifocal IOL
Eligibility Criteria
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.
Sites / Locations
- Hospital Clinic. Casa Maternitat
- Hospital Clinic. Casa maternitat
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Implantation of difractive multifocal IOL
Implantation of monofocal IOL
Arm Description
Outcomes
Primary Outcome Measures
Visual function quality (VF-14)
Secondary Outcome Measures
Visual acuity with and without correction
Determine Expense in glasses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01088282
Brief Title
Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain
Official Title
Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Diffractive multifocal IOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implantation of difractive multifocal IOL
Arm Type
Active Comparator
Arm Title
Implantation of monofocal IOL
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Other Intervention Name(s)
SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator, SN60WF (Alcon labs, Fotworth, Texas) in sham comparator
Intervention Description
Implantation of multifocal or monofocal IOL
Primary Outcome Measure Information:
Title
Visual function quality (VF-14)
Time Frame
At 1 and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Visual acuity with and without correction
Time Frame
at 1 and 3 months post-intervention
Title
Determine Expense in glasses
Time Frame
at 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Torras, MD
Phone
+34 932275667
Email
jtorras@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Torras, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic. Casa Maternitat
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Torras, MD
Phone
+34 932275667
Email
jtorras@gmail.com
First Name & Middle Initial & Last Name & Degree
Josep Torras, MD
Facility Name
Hospital Clinic. Casa maternitat
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Torras, MD
Phone
+34932275667
Email
jtorras@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Josep Torras, MD
12. IPD Sharing Statement
Learn more about this trial
Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain
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