Status:
COMPLETED
Comparison of the Torsional Handpiece to Conventional Handpiece During Routine Phacoemulsification
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract Extraction
Eligibility:
All Genders
50+ years
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 sur...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00366405
Start Date
February 1 2006
End Date
September 1 2007
Last Update
October 4 2010
Active Locations (1)
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1
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425