Visual Performance After RESTOR Implantation

NCT01065064 | Completed Phase 4 DMC

• 1 other identifier: HOB-01/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Assessment

Keywords

Multifocal IOL; ReSTOR IOL

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (1)

RESTOR

EXPERIMENTAL

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

Procedure: RESTOR IOL

Interventions

RESTOR IOL PROCEDURE

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

Also known as: RESTOR IQ MULTIFOCAL IOL

RESTOR

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Oftalmologico de Brasilia: lead

Study Sites (1)

Hospital Oftalmologico de Brasilia

Brasília, Federal District, 70200670, Brazil

Location

Related Publications (3)

• 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.

  PMID: 503440 BACKGROUND

• 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.

  PMID: 19969209 RESULT

• 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.

  PMID: 19787593 RESULT

Study Officials

• PATRICK F TZELIKIS, MD, PhD

  HOB; HBDF; UFMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 9, 2010

Record last verified: 2010-02

Locations

BR (1)