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OpenTrials
Completed

NCT Number: NCT00366405

Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Aug 21, 2006
Registry last updated
Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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