New data show Alcon’s ORA System® with VerifEye™ Technology provides more accurate toric lens guidance than conventional preoperative calculations
Apr 17, 2015
Study results reveal the ORA System® with VerifEye™ Technology reduced postoperative astigmatism to ≤ 0.50 D in significantly more cases than conventional (preoperative) calculations.
New data to be presented during the 2015 American Society of Cataract and Refractive Surgery (ASCRS) meeting, April 17-19, in San Diego, California.
San Diego, California, April 17, 2015– Alcon, the global leader in eye care and a division of Novartis, will present study results comparing the accuracy of toric IOL cylinder power and axis determinations using the ORA System® with VerifEye™ Technology versus conventional (preoperative) cylinder power and axis calculations. The study results will be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting, Sunday, April 19, 2015 in San Diego, California. The ORA System allows surgeons to see incisions and IOL alignment in real time to help provide more consistent astigmatic outcomes for their patients.
The study was a randomized, prospective, observer-masked, contralateral eye study with 111 subjects (222 eyes) included in the study results. Subjects underwent femtosecond laser-assisted cataract surgery with phacoemulsification in both eyes. In each subject, the cylinder power and axis determinations for one eye were performed using the ORA System; the cylinder power and axis determinations for the other eye were obtained via conventional (preoperative) cylinder power and axis determinations. The study found the ORA System reduced postoperative refractive astigmatism to ≤ 0.50 D in significantly more cases than the conventional (preoperative) calculations, 89.2% as compared to 76.7% (p = 0.006).
"Our toric lens outcomes have always been good. This study demonstrated how much more precise they can be by incorporating the information provided by the ORA system with VerifEye when determining IOL power, cylinder power and axis of placement," said Robert J. Cionni, MD., The Eye Institute of Utah. "My results in the study were excellent, 100% of the VerifEye cases had postoperative refractive astigmatism ≤0.50 D. And overall, almost 90% of the study eyes in which ORA with VerifEye was used for toric lens planning had postoperative refractive astigmatism ≤ 0.50 D. This represents a new benchmark in correcting astigmatism with toric IOLs."
About the ORA System with VerifEye Technology
The ORA System with VerifEye Technology allows surgeons to evaluate refractive findings, refine IOL power, cylinder power, and IOL alignment in real time to provide optimal refractive outcomes in cataract surgery. For additional information about the ORA System with VerifEye Technology, please refer to the important product information that accompanies this press release.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. Alcon’s three businesses, Surgical, Pharmaceutical and Vision Care, offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.8 billion in 2014.
Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets.
Beth Bentley Alcon Global Communications
Elizabeth Harness Murphy Alcon Global Communications
References 1. Cionni, Robert J., MD. Axis Determination by Intraoperative Aberrometry Versus Toric Calculator. Poster to be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting, April 17-19, in San Diego, California.
IMPORTANT PRODUCT INFORMATION ABOUT THE ORA SYSTEM
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USE: The ORA System uses wavefront aberrometry data in the measurement and analysis of the refractive power of the eye (i.e. sphere, cylinder, and axis measurements) to support cataract surgical procedures.
CONTRAINDICATIONS: The ORA System is contraindicated for patients: • who have progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation; • who have corneal pathology such as Fuchs’, EBMD, keratoconus, advanced pterygium impairing the cornea, or any other pathology that the physician deems would interfere with the measurement process; • whose preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics; • with visually significant media opacity (such as prominent floaters or asteroid hyalosis) what will either limit or prohibit the measurement process; or • who have received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light. In addition, utilization of iris hooks during an ORA System image capture is contraindicated, because the use of iris hooks will yield inaccurate measurements.
WARNINGS AND PRECAUTIONS: • Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements. • Post refractive keratectomy eyes might yield inaccurate refractive measurement. • The safety and effectiveness of using the data from the ORA System have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations. • The ORA System is intended for use by qualified health personnel only. • Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure. • Do not operate the ORA System in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard.
ATTENTION: Refer to the ORA System Operator’s Manual for a complete description of proper use and maintenance of the ORA System, as well as a complete list of contraindications, warnings and precautions.