Diagnostic technologies focus of industry acquisitions in 2014

Take home

Manufacturers of ophthalmic diagnostic systems are increasingly incorporating advances that improve the predictability of outcomes and integrate technologies.

By Cheryl Guttman Krader; Reviewed by Randall J. Olson, MD, and Mark Packer, MD

The move by Alcon Laboratories to acquire WaveTec Vision and gain full rights to the ORA intraoperative guidance system was the big news in the area of cataract surgery diagnostics technology in 2014.

The development is a testament that the wavefront aberrometer has come a long way since it was first introduced in 2009 and likely signals the beginning of an era when surgeons will increasingly turn to real-time refractive measurements to improve outcomes in cataract surgery, according to Randall J. Olson, MD, and Mark Packer, MD.

More in this issue: Improvements in imaging, corneal biomechanics take center stage

Dr. Packer became involved in the development of the ORA system early on, more than 7 years ago, and he believes that it will now enter the mainstream of cataract surgery. In addition, the fact that Alcon is integrating the ORA system into its Cataract Refractive Surgery Suite may have ramifications for surgeons who are contemplating the purchase of a femtosecond laser.

“Surgeons interested in buying a femtosecond laser may base their decision on access to the intraoperative guidance tool, giving Alcon a competitive advantage in the femtosecond laser market,” said Dr. Packer, who is in private practice, Boulder, CO, and clinical associate professor of ophthalmology, Oregon Health & Science University, Portland.

Dr. Olson observed that various issues affecting the reliability of results achieved with the ORA system seem to have been addressed. That fact together with an increasing number of papers showing that use of the technology provides clinically important improvement in the predictability of refractive outcomes support the idea that it will become an important adjunct.

As another testimonial, Dr. Olson said that while he has been watching with interest information being reported about the ORA system since the beginning, he has now decided that the platform should be part of the Moran Eye Center’s complement of equipment.

“It speaks highly in favor of a device when an administrator who is continuously fielding requests to buy new technologies gives approval for a purchase,” said Dr. Olson, professor and chairman, Department of Ophthalmology and Visual Sciences and chief executive officer, John A. Moran Eye Center, University of Utah, Salt Lake City. “Based on my personal review of the available information, I believe it is definitely time for us to install the ORA system to help surgeons as they strive towards achieving better refractive precision.”

Nevertheless, Dr. Olson still cautioned that surgeons need to recognize use of the system does not guarantee perfect results.

“Surgeons need to remember that when they check the refractive error intraoperatively after putting the lens in the eye, they still don’t know the effective lens position,” he said. “However, most people feel that selecting an IOL power based on refraction in the aphakic state will result in better postoperative accuracy than the best preoperative biometry.”

Dr. Olson also noted that surgeons need to be careful with their technique when obtaining the intraoperative measurements.

“The speculum should not be touching the globe, and surgeons need to know that stromal hydration can induce cylinder,” he said.

Dr. Packer noted that the only other technology that would be considered a direct competitor to the ORA system is the Holos Surgical Wavefront Aberrometer (Clarity Medical Systems), and while it looks promising, it is not yet commercially available.

However, other manufacturers are working to develop integrated systems that couple preoperative measurements with intraoperative guidance. In October, Abbott Medical Optics (AMO) and Carl Zeiss Meditec (CZM) entered into a commercial collaboration that might be expected to result in the integration of the CZM Callisto eye computer-assisted cataract surgery system into the AMO cataract surgery operating suite.

In addition, Bausch + Lomb recently entered into an exclusive license agreement with Cirle to pursue commercialization of Cirle’s 3-D surgical navigation technology, the Cirle Surgical Navigation System.

Also, LensAR entered into an agreement with TrueVision 3D Surgical to integrate the latter company’s TrueGuide system into the LensAR Laser System's technology suite.

“It is clear from all of this industry activity that everyone recognizes the problems associated with existing techniques for calculating IOL power and determining toric IOL alignment and considers intraoperative guidance a big deal,” Dr. Packer said.

“Surgeons don’t want to use ink any more to identify the astigmatic axis and align the toric IOL,” Dr. Packer said. “They want to see the axis through the microscope or on a monitor screen, and they would like their power calculations to take into account posterior corneal astigmatism and to be able to check the refraction with intraoperative aberrometry. Right now, Alcon has most of the necessary equipment to achieve all these goals.”

He noted hearing that prior to the acquisition, Alcon requested WaveTec to conduct a randomized, fellow eye, masked trial in order to document that use of the ORA system improved refractive outcomes with toric IOL procedures. The results showed a statistically significant and clinically meaningful difference favoring use of the intraoperative guidance tool. In the primary endpoint analysis, 89% of eyes managed with intraoperative aberrometry versus only 77% of those operated on with standard techniques had ≤0.5 D of residual refractive astigmatism.

“This was an interesting request from Alcon and it is a study that I wish WaveTec had initiated 5 years ago,” Dr. Packer said. “However, better late than never, and we finally have the hard data showing an advantage for intraoperative guidance of toric IOL alignment.”

He also cited a paper published in January, 2014, by Ianchulev et al. showing that use of the ORA system to guide IOL power selection in postLASIK eyes resulted in significantly better accuracy compared with the surgeon’s best preoperative choice (determined by the surgeon using all available clinical data) or use of the Haigis L or Shammas IOL formulas [Ianchulev T, et al. Ophthalmology. 2014;121:56-60].

As another development during the past 12 months in the realm of diagnostics for cataract surgery, Dr. Packer mentioned the FDA approval of the Inflammadry test (Rapid Pathogen Screening) for matrix metalloproteinase-9 in the tear film (November 2013). He said it is noteworthy considering the growing understanding of the importance of identifying and managing existing ocular surface disease in patients undergoing cataract surgery, particularly those receiving advanced technology IOLs.

“Dry eye disease, which is most often due to meibomian gland dysfunction, is the most common problem that exists in ophthalmology,” Dr. Packer said. “There is definitely a need for some new treatment options and hopefully those are coming along soon.

“In the mean time, however, the new test for MMP-9 and the device for measuring tear film osmolarity (TearLab) offer advances as objective in-office diagnostic tools that can help us figure out who is affected by ocular surface disease and therefore at risk for a poor outcome after surgery, as well as who might benefit from specific anti-inflammatory treatment options,” he said.

Randall J. Olson, MD

E: randallj.olson@hsc.utah.edu

Dr. Olson has no relevant financial interests to disclose.

Mark Packer, MD

E: mark@markpackerconsulting.com

Dr. Packer is a consultant to Alcon Laboratories, Bausch + Lomb, Lensar and TrueVision Systems. He had equity in WaveTec Vision Systems.