PresbyopiaNCT01088282
Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain
A study testing Cataract surgery in people with Presbyopia, run by University of Barcelona at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic. Casa Maternitat
Barcelona, Barcelona, 08028
Josep Torras, MD, +34 932275667, jtorras@gmail.com
Josep Torras, MD
Hospital Clinic. Casa maternitat
Barcelona, Barcelona, 08028
Josep Torras, MD, +34932275667, jtorras@clinic.ub.es
Josep Torras, MD
About this study
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.
Read more
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.
- Conditions
- Presbyopia
- Being tested
- Cataract surgery
- Keywords
- Diffractive multifocal IOL
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Also called SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator, SN60WF (Alcon labs, Fotworth, Texas) in sham comparator
Implantation of multifocal or monofocal IOL
| Study group | Role | What they receive |
|---|---|---|
| Implantation of difractive multifocal IOL | Active comparator | Not described Receives: Procedure: Cataract surgery |
| Implantation of monofocal IOL | Sham comparator | Not described Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual function quality (VF-14)
Measured: At 1 and 3 months post-intervention
Secondary outcomes (2)
Visual acuity with and without correction
Measured: at 1 and 3 months post-intervention
Determine Expense in glasses
Measured: at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Josep Torras, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088282
- Sponsor's protocol ID
- ECICOFPALIORES09
- Status last verified
- Feb 2010
- First submitted
- 16 Mar 2010
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants
- ClinicalTrials.gov ID
- NCT01088282
- Acronym / sponsor ID
- ECICOFPALIORES09
- Conditions
- Presbyopia
- Keywords
- Diffractive multifocal IOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantation of difractive multifocal IOL | Active comparator | Procedure: Cataract surgery |
| Implantation of monofocal IOL | Sham comparator | Procedure: Cataract surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryAlso: SN6AD1 (Alcon labs, Fotworth, Texas) in active comparator, SN60WF (Alcon labs, Fotworth, Texas) in sham comparatorImplantation of multifocal or monofocal IOL | Procedure or surgery | Implantation of difractive multifocal IOL, Implantation of monofocal IOL |
Primary outcome
Visual function quality (VF-14)
Time frame: At 1 and 3 months post-intervention
2 secondary outcomes
Visual acuity with and without correction
Time frame: at 1 and 3 months post-intervention
Determine Expense in glasses
Time frame: at 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Torras, MD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Presbyopia, run by University of Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Torras, MD (+34 932275667, jtorras@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual function quality (VF-14) (time frame: At 1 and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2010.