A clinical study of the Catalys Precision Laser System developed by OptiMedica Corp. has shown that it can help achieve precision in the critical procedures of a cataract surgery.
The results of the study were published in the peer-reviewed journal Science Translational Medicine
("Femtosecond Laser-Assisted Cataract Surgery with Integrated Optical Coherence Tomography," Volume 2, Issue 58, November 17, 2010).
"These study results clearly indicate that a femtosecond laser with integrated Ocular Coherence Tomography (OCT) imaging, advanced optics and control software can provide multiple benefits for cataract surgery," said the study's lead author Daniel Palanker, associate professor, Department of Ophthalmology and Hansen Experimental Physics Laboratory, Stanford University. "We believe the new laser-assisted technique represents a significant scientific and clinical advancement that will make cataract surgery much more precise and reproducible, and we are gratified that Science Translational Medicine has recognized its importance and potential."
As reported in the published study, approximately one third of Americans will undergo cataract surgery in their lifetime. While advancements in surgical technique have occurred over the last several decades, several critical steps remain manual in nature and can only be performed with limited precision. OptiMedica developed the Catalys Precision Laser System to dramatically improve the cataract procedure by replacing its inconsistent, manual steps.
Catalys is designed to perform four incisions: capsulotomy (a circular incision in the lens capsule), lens fragmentation (segmenting and softening of the lens to prepare for removal), relaxing incisions (cuts to correct astigmatism), and cataract incisions (cuts to allow insertion of the surgical tools). Results of the clinical study, which compared 29 laser-treated eyes with 30 manually treated eyes, showed great improvement across these steps. Authors reported:
- A 12-fold improvement in precision of sizing the capsulotomy with Catalys, as compared to the manual technique, and a five-fold improvement in the precision of the capsulotomy shape. These findings are significant, as capsulotomy shape and size are known to have a critical impact on refractive outcomes.
- A more than two-fold improvement in capsulotomy strength. This has the potential to make the procedure safer by reducing the potential for lens capsule rupture.
- A 40 percent reduction in the use of ultrasound energy (Cumulative Dispersed Energy) during phacoemulsification, which has the potential to simplify the process of emulsifying and removing the lens.
"The significant gains in precision we were able to achieve in the clinical study of Catalys represent an incredibly exciting development in the field of cataract surgery," said the publication's co-author William Culbertson, M.D., Professor of Ophthalmology, The Lou Higgins Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami. "A more precise procedure will enable cataract surgeons to more accurately position the IOL, and this is key to visual outcomes."
Dr. Culbertson is chair of OptiMedica's Medical Advisory Board, a group of esteemed cataract experts from around the world who have worked closely with the company during every step of the Catalys Precision Laser System's development. Also on the list of study co-authors are OptiMedica Board of Directors member Mark Blumenkranz, M.D., professor and chairman of the Department of Ophthalmology at Stanford University, and OptiMedica Medical Advisory Board members Neil J. Friedman, M.D., partner, Mid-Peninsula Ophthalmology Medical Group and adjunct clinical associate professor, Stanford University School of Medicine; Barry S. Seibel, M.D., clinical assistant professor of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine, UCLA; Juan F. Batlle, M.D., Centro Laser, Santo Domingo, Dominican Republic; and Jonathan H. Talamo, M.D., associate clinical professor of ophthalmology, Harvard Medical School, Talamo Laser Eye Consultants.
"We are enormously proud of the precision demonstrated in the clinical study of Catalys, and we are very gratified to have the data published in the prestigious journal Science Translational Medicine," said Mark J. Forchette, president and chief executive officer, OptiMedica. "We are privileged to partner with such an outstanding team of scientists and clinicians who have worked tirelessly with us for the last several years to bring a whole new level of innovation to cataract surgery."