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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014