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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of difractive multifocal IOL | Active Comparator |
| |
| Implantation of monofocal IOL | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery | Procedure | Implantation of multifocal or monofocal IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual function quality (VF-14) | At 1 and 3 months post-intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Torras, MD | Contact | +34 932275667 | jtorras@clinic.ub.es |
| Name | Affiliation | Role |
|---|---|---|
| Josep Torras, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic. Casa Maternitat | Barcelona | Barcelona | 08028 | Spain |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Hospital Clinic. Casa maternitat | Barcelona | Barcelona | 08028 | Spain |
|