Visual Performance After RESTOR Implantation

This study has been completed.
Sponsor:
Information provided by:
Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier:
NCT01065064
First received: February 8, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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

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:
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 April 15, 2014