Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2009-01-31
2009-12-31
Brief Summary
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Detailed Description
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Prospective study of 50 patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation. Uncorrected distance vision acuity (UDVA), corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA), and distance-corrected intermediate visual acuity (DCIVA) were measured postoperatively. A patient-satisfaction and visual phenomena questionnaire was administered at the end of the study.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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RESTOR
Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.
RESTOR IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery
Interventions
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RESTOR IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any race
* Either gender
* Diagnosis of cataracts both eyes
* Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
* Subjects must have \< 1.00 diopter of astigmatism
* Biometry results for the Restore patients should target emmetropia or +0.25.
Exclusion Criteria
* Retinal abnormalities
* Diabetes mellitus steroid or immunosuppressive treatment
* Connective tissue diseases
45 Years
85 Years
ALL
Yes
Sponsors
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Hospital Oftalmologico de Brasilia
OTHER
Responsible Party
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HOSPITAL OFTALMOLOGICO DE BRASILIA; UFMG; HBDF
Principal Investigators
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PATRICK F TZELIKIS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HOB; HBDF; UFMG
Locations
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Hospital Oftalmologico de Brasilia
Brasília, Federal District, Brazil
Countries
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References
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Artem'eva LS, Asin BA, Guliaev AA. [Method of prolonged active drainage after operations on the joints in rheumatoid arthritis]. Ortop Travmatol Protez. 1979 Aug;(8):28-9. No abstract available. Russian.
Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.
Alfonso JF, Fernandez-Vega L, Orti S, Ferrer-Blasco T, Montes-Mico R. Refractive and visual results after implantation of the AcrySof ReSTOR IOL in high and low hyperopic eyes. Eur J Ophthalmol. 2009 Sep-Oct;19(5):748-53. doi: 10.1177/112067210901900511.
Other Identifiers
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HOB-01/09
Identifier Type: -
Identifier Source: org_study_id
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