Catalys Precision Laser System
The Catalys Precision Laser System (OptiMedica Corp., Santa Clara, California) combines an ultra-rapid femtosecond laser, integrated optical coherence tomography (OCT) imaging, and OptiMedica’s pattern scanning technology. According to the company, this laser is capable of performing capsulotomy, lens fragmentation, arcuate relaxing incisions, and cataract incisions. The technological hallmarks of the Catalys system include an innovative Liquid Optics Interface that optimizes the optical path to the patient’s eye and a proprietary Integral Guidance System that ensures the femtosecond laser pulses are delivered precisely to the intended location.
Douglas D. Koch, MD, of the Cullen Eye Institute, Baylor College of Medicine, Houston, is among the surgeons with clinical experience using Catalys. “OptiMedica’s Catalys Precision Laser System has demonstrated amazingly precise incisions,” he told CRST Europe. “For instance, our study found that not only is the laser accurate to within 27 μm of intended size for the capsulotomy, but the standard deviation is only 25 μm.” Dr. Koch treated patients with Catalys at Centro Laser in the Dominican Republic and found that the laser was capable of creating a perfectly sized, shaped, and centered capsulotomy and of dramatically softening a dense nucleus. “The lens fragmentation made phacoemulsification much easier, and studies have shown that about 40% less total energy is required to remove the cataract. We also found about 40% reduction in active phaco steps.”
As a member of OptiMedica’s Medical Advisory Board, Dr. Koch helped design Catalys’ ergonomic controls and user interface. “Over time, I believe that we will appreciate beyond our expectations of this system: perfect, self-sealing incisions that reduce the risk of endophthalmitis; remarkably precise peripheral corneal relaxing incisions; customized shape, size, and location of the capsulorrhexis; and greatly enhanced safety and speed of nuclear removal,” he said.
The Catalys has not been cleared by the US Food and Drug Administration (FDA) and has not yet received the Conformité Européenne (CE) Mark. In a recent clinical study by Palanker et al,1 the Catalys improved the precision of sizing the capsulotomy by a factor of 12 compared with manual technique. The system also demonstrated a fivefold improvement in precision of capsulotomy shape and more than a twofold improvement in capsulotomy strength. The use of the laser also resulted in a 40% reduction in ultrasound energy use during phacoemulsification.
- Palanker D,Blumenkranz M,Andersen D,et al.Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography.Sci Transl Med.2010;2(58):58ra85.
Customlens (Technolas Perfect Vision GmbH, Munich, Germany) is a modular addition to the Technolas Femtosecond Workstation for performing cataract and refractive surgery with one device. According to the company, the Customlens femtosecond laser was designed to perform anterior capsulotomy, lens fragmentation, corneal incisions, and arcuate relaxing incisions. The Technolas Femtosecond Workstation can also perform the Intracor procedure, create LASIK flaps, and be used for other corneal therapeutic indications.
The device features Technolas’ custom Curved Patient Interface, which keeps corneal deformation to a minimum to allow precise 3-D cutting. The system’s built-in, online OCT module enables precise planning (placement of cuts) and monitoring (position of cuts) of the cataract procedures. Company literature states that a standalone cataract version of the femtosecond laser will also be available.
“In my experience using the Customlens procedure on the Technolas Femtosecond laser, the anterior capsulotomies can be performed with a high degree of accuracy and consistency compared with manual phaco,” Luis A. Ruiz, MD, of the Centro Oftalmológico Colombiano in Bogatá, Colombia, told CRST Europe. “Lens fragmentation can also be safely and efficiently conducted using a number of different cutting techniques. In addition, the software is easy to use and customizable.”
According to Technolas, clinical evaluations of Customlens are ongoing but have demonstrated statistically significant differences between laser anterior capsulotomy and manual capsulorrhexis in terms of the accuracy and precision of diameter, circularity, and centration. Further data will be presented at forthcoming regional congresses, the company said. Customlens is not yet approved for use in Europe or the United States, but product availability and regulatory approvals for the module are expected for the second half of 2011, the company said.
LensAR Laser System
The LensAR Laser System (LensAR, Inc., Winter Park, Florida) integrates an advanced refractive cataract laser with proprietary 3-D confocal structured illumination (CSI) technology to provide precise, automated 3-D surgical guidance.
The automated 3D-CSI biometric system produces seamless high-resolution, high-definition imaging from the anterior surface of the cornea to the posterior capsule. The technology automatically builds a 3-D model of the anterior segment, using ray tracing with ocular media refractive indexes, and calculates optimal cutting patterns across all grades of cataract. The LensAR Laser System is ergonomically designed and mobile, with three touchscreens for diverse surgical requirements and preferences.The nonapplanting suction fixation device of the patient interface does not directly touch the cornea, thereby preserving the eye’s natural anatomy.
In a prospective, controlled study by Ramon Naranjo-Tackman, MD, of APEC Hospital in Mexico City, capsulotomies created with the LensAR laser were significantly more precise than those created manually, the company reported. In additional studies, the LensAR laser cleanly cut up to grade 4 cataracts and demonstrated significantly reduced ultrasound energy use, measured as cumulative dissipated energy (CDE). Lower CDE per cataract case has been shown to reduce the risk for endothelial cell and corneal damage and improve surgical efficiency, according to the company. After a recent algorithm upgrade, Harvey Uy, MD, from Makati City, Philippines, has fragmented and removed cataracts as hard as grade 5 with the laser.
The LensAR Las System has received 510(k) clearance for anterior capsulotomy during cataract surgery. The indication for use in lens fragmentation (chop and cylinder patterns) is under active review by the FDA, the company said.
“I was privileged to have been the first US surgeon to use the LensAR Laser System in Mexico City,” Louis “Skip” Nichamin, MD, told CRST Europe. “I was impressed with the accuracy and reproducibility in achieving excellent centration, as well as how smoothly and efficiently each of the cases went. The 3D-CSI imaging system is largely responsible for the efficiency and accuracy of the treatment algorithm. Even in most advanced grades of cataract, the lens fragmentation and extraction process was considerably more efficient and successful than conventional phacoemulsification.”
The customizable LenSx Laser (Alcon Laboratories, Inc., Fort Worth, Texas) enables surgeons to perform key steps of cataract surgery with image-guided visualization and micron-level laser precision. According to Alcon, which recently acquired LenSx Lasers, Inc., the device is designed to fragment the lens nucleus, perform a perfectly sized and centered capsulotomy, and create all corneal incisions. The LenSx Laser has integrated proprietary OCT technology to provide 3-D views of the ocular anatomy and allow precise localization of surgical laser pulses.
In 2009, the LenSx Laser received 510(k) clearance from the FDA for anterior capsulotomy, becoming the first femtosecond laser approved for a cataract indication. The company has since received two more 510(k) clearances for use of its femtosecond laser in laser phacofragmentation and corneal and arcuate incisions during cataract surgery.
Initial clinical evaluation of the LenSx Laser began in 2008 with Zoltan Nagy, MD, of Semmelweiss University in Budapest, Hungary. In an early study, Dr. Nagy demonstrated that lens fragmentation with the LenSx Laser significantly reduced average phaco power compared with a traditional manual technique. Additionally, all laser capsulotomies achieved perfect centration and exact intended diameter, but only 10% of manually created capsulorrhexes achieved a similar diameter accuracy of ±0.25 mm. Corneal incisions created with the laser were also highly reproducible, according to the company.
In an interview with CRST Europe, Dr. Nagy said that his study patients have been accepting of the femtosecond laser treatment. “They are enthusiastic and recommend [the procedure] to other patients.”