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Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00934622
First Posted: July 8, 2009
Last Update Posted: May 6, 2010
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.
Information provided by:
Alcon Research
  Purpose
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

Condition Intervention Phase
Cataract Device: AcrySof® ReSTOR® Aspheric IOL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery ]
    Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


Secondary Outcome Measures:
  • Spectacle Independence [ Time Frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery ]
    Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.


Enrollment: 76
Study Start Date: November 2007
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Device: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21 years or older;
  • need spherical correction between 10-30 Diopters (D);
  • corneal astigmatism less than 0.75D as measured by keratometry;
  • willing to sign an Informed Consent Form and complete all visits;
  • pupil dilation greater than 6mm;
  • expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria:

  • Women of childbearing potential;
  • irregular corneal astigmatism;
  • keratopathy/keratectasia;
  • cornea inflammation or edema;
  • cornea reshaping surgery;
  • corneal dystrophy;corneal transplant;
  • amblyopia;
  • glaucoma;
  • Retinal Pigment Epitheliopathy (RPE)/Macular changes;
  • proliferative diabetic retinopathy
  Contacts and Locations
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): NCT00934622


Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Doug Hubatsch\Clinical Research Director, Alcon Research
ClinicalTrials.gov Identifier: NCT00934622     History of Changes
Other Study ID Numbers: ALCONsur002.07
First Submitted: July 7, 2009
First Posted: July 8, 2009
Results First Submitted: March 25, 2010
Results First Posted: May 6, 2010
Last Update Posted: May 6, 2010
Last Verified: May 2010

Keywords provided by Alcon Research:
AcrySof
ReSTOR
Aspheric IOL
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases