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Visual Performance After RESTOR Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 8, 2010
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date February 9, 2010
Study Start Date  ICMJE January 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Performance After RESTOR Implantation
Official Title  ICMJE Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Refractive Assessment
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: RESTOR
Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.
Intervention: Procedure: RESTOR IOL
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2010)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065064
Other Study ID Numbers  ICMJE HOB-01/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PATRICK FRENSEL DE MORAES TZELIKIS, HOSPITAL OFTALMOLOGICO DE BRASILIA; UFMG; HBDF
Study Sponsor  ICMJE Hospital Oftalmologico de Brasilia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PATRICK F TZELIKIS, MD, PhD HOB; HBDF; UFMG
PRS Account Hospital Oftalmologico de Brasilia
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP