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Visual Performance After RESTOR Implantation

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ClinicalTrials.gov Identifier: NCT01065064
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
Hospital Oftalmologico de Brasilia

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.

Condition or disease Intervention/treatment Phase
Refractive Assessment Procedure: RESTOR IOL Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens
Study Start Date : January 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation. [ Time Frame: 6 months ]


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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