Visual Performance After RESTOR Implantation - Full Text View

Purpose

The purpose of this study is to evaluate the distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Condition	Intervention	Phase
Refractive Assessment	Procedure: RESTOR IOL	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens

Further study details as provided by Hospital Oftalmologico de Brasilia:

Primary Outcome Measures:

To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	January 2009
Study Completion Date:	December 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RESTOR Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.	Procedure: 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 Name: RESTOR IQ MULTIFOCAL IOL

Arms

Assigned Interventions

Experimental: RESTOR

Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.

Procedure: 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 Name: RESTOR IQ MULTIFOCAL IOL

Detailed Description:

To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

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.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Cataract
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:

Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
Retinal abnormalities
Diabetes mellitus steroid or immunosuppressive treatment
Connective tissue diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065064

Locations

Brazil
Hospital Oftalmologico de Brasilia
Brasilia, DF, Brazil, 70200670

Sponsors and Collaborators

Hospital Oftalmologico de Brasilia

Investigators

Principal Investigator:

PATRICK F TZELIKIS, MD, PhD

HOB; HBDF; UFMG

More Information

Publications:

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.

Alfonso JF, Fernández-Vega L, Ortí S, Ferrer-Blasco T, Montés-Micó 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.

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. Russian. No abstract available.

Responsible Party:	PATRICK FRENSEL DE MORAES TZELIKIS, HOSPITAL OFTALMOLOGICO DE BRASILIA; UFMG; HBDF
ClinicalTrials.gov Identifier:	NCT01065064 History of Changes
Other Study ID Numbers:	HOB-01/09
Study First Received:	February 8, 2010
Last Updated:	February 8, 2010
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Oftalmologico de Brasilia:

Multifocal IOL
ReSTOR IOL

ClinicalTrials.gov processed this record on May 22, 2013