Cataract Clinical Trial
Official title:
Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.
In this prospective, comparative, masked study, patients will be randomly assigned to have
torsional coaxial microincision cataract surgery using either the mini-flared 45-degree
Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include
preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial
cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT).
Intraoperative measurements will include phaco time, torsional time, aspiration time, case
time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).
The study was performed according to established ethical standards for clinical research
Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between
November 2010 and February of 2011. All surgeries will be performed at the University of Sao
Paulo. Physicians conducting postoperative evaluation will not have access to patients'
medical records. Exclusion criteria will be previous ocular surgery, central endothelial
cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg,
amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective
tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior
capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will
be subsequently excluded.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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