IDE trial finds iStent inject results in IOP reduction

Trial results, comparing inject to cataract surgery, announced at ASCRS.

By Robert Stoneback, associate editor

Results of Glaukos’ investigational device exemption pivotal trial show that most cataract patients implanted with an iStent inject achieve a 20% or greater IOP reduction than those who undergo cataract surgery alone.

Findings from the study were presented at April’s ASCRS meeting in Washington, D.C. Of the study’s 387 subjects receiving the iStent inject along with cataract surgery, 75.3% had their IOP decrease after 24 months, compared to 61.9% of the 118 subjects who had cataract surgery alone. Also, the mean, unmedicated IOP reduction for the iStent inject group at 24 months was 6.9 mm Hg and for the cataract-only group was 5.4 mm Hg.

“The iStent inject data recently released by Glaukos demonstrates excellent reductions in IOP and medication usage two years after stent placement,” said Nathan Radcliffe, MD, clinical associate professor of ophthalmology at New York Eye and Ear Infirmary and surgeon at the New York Eye Surgery Center.

Additional findings included:

• 75% reduction in mean number of medications in the inject group, compared to 47% in the surgery-only group, at 23 months;
• 31% mean reduction in unmedicated, post-washout IOP to 17.1 mm Hg for the inject group, and 24.8 mm Hg in cataract-only at 24 months; and
• Unmedicated mean IOP at 18 mm Hg or lower in 62.6% for the inject group and 49.2% in the surgery group at 24 months.

Jason Bacharach, MD, founder of California-based North Bay Eye Associates, also had a favorable impression of the study results, saying the iStent inject had an “impressive safety profile.” In the study, the rate of adverse events was similar between the two groups.

The iStent inject, which was submitted for pre-market approval to the FDA in December, helps improve the aqueous humor outflow into Schlemm’s canal to reduce IOP in patients with mild to moderate glaucoma undergoing cataract surgery. It is not yet available in the United States.

At approximately 0.23 mm x 0.36 mm, Glaukos believes the iStent inject would be the smallest medical device to ever be approved by the FDA. OM

CyPass Ultra comes to the United States

New device increases preloading efficiency in cataract surgery in glaucoma patients.

By Frieda Wiley, contributing editor

In efforts to help U.S. clinicians optimize outcomes in glaucoma patients, the FDA recently cleared the CyPass Ultra. Manufactured by Alcon, the device is designed to streamline the efficiency of loading in patients undergoing cataract surgery who have mild to moderate primary open-angle glaucoma. It received premarket status approval on Dec. 18, 2017, and, according to the company, eliminates several steps required in the preloading of its predecessor, the CyPass Micro-Stent.

“The inserter requires multiple steps to get the CyPass loaded in the original system,” says Constance Okeke, MD, MSCE, a glaucoma specialist at Virginia Eye Consultants and speaker and consultant for Alcon. “By simplifying the loading aspect, these seemingly small steps make an impact with easier technology and staff being more comfortable with handling the device.”

The CyPass Micro-Stent has two different parts that require multiple steps in the loading process. The original loading process uses an applier that interacts with the stent-containing loading device, which must be removed for loading to occur.

Conversely, the CyPass Ultra System houses all device components in a single unit. The new design only requires surgical staff to push a button and remove the tip. Increased efficiency translates into safer, more consistent control of IOP in the long run, Alcon says.

According to Dr. Okeke, the reduced number of steps and handling simplicity offer an additional advantage beyond efficiency. “I have had nurses feel uneasy loading inserters,” she says. “Sometimes one might say, ‘The handle is so bulky that it doesn’t fit my hand well,’ or, ‘It’s a little complicated to insert and it takes a lot of steps to do this.’” The newer model offers much greater comfort and ease of use, she says.

Alcon will feature the clinical data reflecting the surgical and clinical benefits of using CyPass Ultra as the primary component of its clinical program at the ASCRS Young Eye Surgeons Advanced Cataract Training meeting in September.

While several studies have shown utilizing the device decreases IOP over periods ranging from 12 to 48 months, Alcon plans to recruit 4,000 patients who received CyPass Micro-Stent implantation into a five-year study to further investigate the relevance and utility of this device in clinical ophthalmology. OM

Zeiss seeks new opportunities through digitalization

Cloud-based Veracity platform was among Zeiss products at ASCRS.

By Robert Stoneback, associate editor

Zeiss’ cloud-based Veracity platform, on display at April’s annual ASCRS meeting, represents the company’s focus on improving practices through digitalization.

“We are continuing to expand our portfolio of integrated digital solutions that span from the office to the OR,” said Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec, via press release. “Digitalization presents many opportunities to improve treatment outcomes and increase the efficiency of clinical workflows. Our goal is to continue to provide doctors and surgeons advanced technologies to help them care for their patients in the best way possible.”

The Veracity is a cloud-based data platform for cataract surgery planning, logistics, treatment, risk management and analysis. It can provide practices with personalized patient care, allowing for greater efficiency and risk reduction.

Also on display from Zeiss at ASCRS 2018 was the Cataract Suite markerless, a computer-assisted surgery system designed to create a markerless toric IOL alignment. The suite features the Opmi Lumera surgical microscope, which uses intraoperative OCT technology to enhance visualization, and Callisto eye computer-assisted surgery system, which integrates with the Opmi Lumera and allows for easy transfer of patient data to the operating room.

Zeiss’ IOLMaster 700 can also be integrated into the Cataract Suite markerless to help further achieve target refraction and reduce refractive surprises.

Also, Zeiss announced that its ReLEx SMILE laser eye surgery procedure surpassed 1 million procedures performed worldwide. The SMILE procedure, which uses Zeiss’ VisuMax femtosecond laser, was first performed last year and has since been adopted by more than 1,300 surgeons in 69 countries. A new clinical trial has begun outside the United States for use of SMILE in hyperopic patients. OM

TO THE EDITOR

Operating for psychiatric disease

I can honestly say the profession and practice of ophthalmology never ceases to astound me. I have been in practice for almost 30 years, and I am still left speechless sometimes by the things I read in our professional magazines and newspapers.

Your April 2018 edition was remarkable. First, there were real actual ophthalmologists who referred to themselves as “Key Opinion Leaders.” This is a title they and I guess others have given to themselves. In the past, we had professors, teachers, clinicians and researchers. This was a somewhat marginal group who gave presentations, were often paid for their services and opinions by ophthalmic industry companies and who we referred to kindly as researchers and industry spokesmen/women. Somewhat unkindly we called them “talking heads,” and some were little more than shills for various industrial products. Now, they have decided to call themselves “Key Opinion Leaders.”

They used to try to scare practitioners and influence behavior by telling us the “paradigm had shifted.” We had to follow their directions, or we would be left behind. Now I guess we have to follow them because they are “Key Opinion Leaders.” I probably will not. I do not even have the faintest idea of what qualifies one as a “Key Opinion Leader.” Is there a school or a degree involved? An election?

Next, in Dr. Paul Koch’s article “Where’s Freud When You Need Him” (tinyurl.com/Apr18MPE ), we have a different astonishment. I have met Dr. Koch, and he is a physician of peerless quality and professionalism. I was stupefied to read of his patient encounter. He knowingly performed a surgery that he knew had no medical indication on a patient with psychiatric problems. He clearly told us that he lied to the patient about what he found and what he did. Rather than take the time to address the patient’s true psychiatric and emotional illnesses, he took the patient to the OR and actually performed a surgery with “sham” indications, “sham” benefits and real potential complications. His article could be used in a courtroom as an expert testimony against himself. In what realm of medicine do we trick and deceive our patients with inappropriate surgeries, whether or not our intentions (and outcomes) are good? Psychiatric illness is as real as any other and deserves appropriate treatment, not sham deceptions.

A physician can never lie to a patient. The absolute basic requirement of any doctor/patient relationship is that the patient can believe the doctor is telling them the truth. Deception is worse than malpractice, because there can be no professional relationship with dishonesty. A physician can fail, but never lie.

Somehow, this profound ethical lapse failed to draw the attention of the editors and “Key Opinion Leaders” who publish Ophthalmology Management. Naive young physicians might read it and believe that performing inappropriate surgeries on psychiatric patients is an acceptable, ethical course of action.

And the band plays on.

— Mark Johnson, MD, FACS, Venice, Fla.