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Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT00366405
Collaborator
(none)
30
Enrollment
1
Location
19
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the visual outcomes, amount of inflammation, endothelial cell loss, and the efficiency of a torsional handpiece compared to a conventional handpiece during surgery to remove your cataracts.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    With the introduction of new phaco-emulsification systems, the cataract surgery has become a very safe procedure. The new machines combine fewer surges, lower amount of ultrasound and more controlled anterior chamber depth, as well as lower incidence of thermal burns of the incision site.1-4

    Alcon's Infiniti Vision System phacoemulsification machine includes now a torsional handpiece (OZiL™). The goal of OZiL™ is to minimize the surgery impact by reducing temperature increase, turbulence and incision stress. This handpiece has a sideways movement that does not repel the cataract during its extraction making the removal more continuous, maintains occlusion which facilitates vacuum build-up and reduces flow through the anterior chamber decreasing turbulence, therefore reducing the likelihood of lens particles damaging the corneal endothelial cells.

    The purpose of this study is to compare visual outcomes, induction of inflammation, endothelial cell loss and efficiency of the torsional handpiece vs. the conventional phacoemulsification handpiece when using the Alcon Infiniti Vision System.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification
    Study Start Date :
    Feb 1, 2006
    Actual Study Completion Date :
    Sep 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Bilateral senile cataracts.

      • Cataract density up to 3+.

      • 50 years of age or older.

      • Patient must desire cataract extraction.

      • Expected maximum of 4 weeks and minimum of 1 week interval between first and second eye surgeries.

      • Willing and able to comply with scheduled visits and other study procedures.

      Exclusion Criteria:

      • Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, macular edema, retinal detachment, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration with visual acuity of less than 20/40, glaucoma with the presence of visual field defects

      • Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.

      • Low endothelial cell count (less than 1500 cells/mm2)

      • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.

      • Any clinically significant, serious or severe medical or psychiatric condition.

      • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

      • Previous intraocular or corneal surgery.

      • Other ocular surgery at the time of the cataract extraction.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Storm Eye Institute, Medical University of South Carolina Charleston South Carolina United States 29425

      Sponsors and Collaborators

      • Medical University of South Carolina

      Investigators

      • Principal Investigator: Kerry D Solomon, MD, Medical University of South Carolina

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00366405
      Other Study ID Numbers:
      • MRC-06-001
      First Posted:
      Aug 21, 2006
      Last Update Posted:
      Oct 4, 2010
      Last Verified:
      Oct 1, 2010
      Keywords provided by , ,
      cataract
      Additional relevant MeSH terms:
      Cataract

      Study Results

      No Results Posted as of Oct 4, 2010