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Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification

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ClinicalTrials.gov Identifier: NCT00366405
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : October 4, 2010
Sponsor:
Information provided by:
Medical University of South Carolina

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
Cataract Extraction

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 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 : February 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract





Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.

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): NCT00366405


Locations
United States, South Carolina
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

Responsible Party: Kerry D. Solomon, Medcial University of South Carolina
ClinicalTrials.gov Identifier: NCT00366405     History of Changes
Other Study ID Numbers: MRC-06-001
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by Medical University of South Carolina:
cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases