Year in review: Cataract surgery

Safety and effectiveness of cataract surgery continue to improve, thanks to ongoing innovations.

Looking back over the past year and into the near future, Eric D. Donnenfeld, MD, Robert H. Osher, MD, and Mark Packer, MD, spoke to Ophthalmology Times about developments in diagnostic products and other tools used in cataract surgery. In addition, they discussed combination microinvasive glaucoma surgery (MIGS) and office-based surgery as new trends.

Femtosecond laser update

Femtosecond laser-assisted cataract surgery (FLACS) remained a topic for debate in 2016.  

Dr. Packer, clinical associate professor of ophthalmology, Oregon Health & Science University, Portland, said there is still no compelling evidence that the benefits of FLACS are significant enough to justify the cost. Discussing the various functions of the laser, Dr. Packer acknowledged that its use for lens fragmentation is advantageous in dense cataracts for reducing ultrasound energy use. However, the laser’s value for this application is limited in the United States where most cataracts are grade 2+ or less.

For capsulotomy, there is no question that the femtosecond laser outperforms a manual technique in terms of creating a more precisely sized, shaped, and centered capsule opening. However, controversy continues over the strength of the laser capsulotomy edge.

To date, one of the best studies investigating this issue was published in 2016 [Thompson VM, et al. Ophthalmology. 2016;123(2):265-274], Dr. Packer said. It compared edge tear strength of capsulotomies created with a femtosecond laser (LenSx, Alcon), manually, and using an investigational thermal-based device (Zepto Capsulotomy System, Minosys) and found the capsulotomies created with the thermal technology had significantly greater edge strength than those made with the laser or manually.

The laser is also very effective for making the corneal incisions for cataract surgery, Dr. Packer noted. Nevertheless, many surgeons still use a blade because it is quicker and more reliable, especially in eyes with arcus senilis that can be hard to cut through with a laser.

“I think in the future, the value of the femtosecond laser will be realized through its integration with preoperative diagnostics to guide astigmatic correction through arcuate incisions or for placing a reference mark for toric lenses,” he said.

Capsulotomy devices

Meanwhile, Zepto and two other thermal-based technologies-CAPSULaser (CAPSULaser) and ApertureCTC Precision Capsulotomy System (International BioMedical Devices)-are being anticipated for providing more affordable alternatives to the femtosecond laser for performing precision capsulotomy.

“These devices are attractive for offering a middle ground between a manual needle rhexis and the extremely expensive femtosecond laser,” said Dr. Osher, professor of ophthalmology, University of Cincinnati School of Medicine, and medical director emeritus, Cincinnati Eye Institute, Cincinnati, OH.

Zepto is furthest along in its premarketing development and was conducting a single-arm clinical trial for 510(k) approval. The technology uses a soft suction cup to pull the capsule into contact with a nitinol capsulotomy ring. Rapid multipulse energy in the ring causes phase transition in water molecules that results in cutting of the capsule.

Dr. Osher expressed some concern about the size of the capsule opening created with the Zepto.

“According to Dr. David Chang’s presentation at The Cutting Edge Symposium during AAO 2016, it is only 5.25 mm in diameter, which doesn’t leave much leeway considering how easy it is to misjudge the center of the visual axis,” he said.

Dr. Osher has been involved in the evaluation of the CapsuLASER, a device that attaches to the bottom of the surgical microscope. The procedure involves instillation of trypan blue as a chromophore to stain the capsule. After the dye is rinsed out of the eye, the laser rotates 360° and creates the circular capsulotomy in just 2 seconds. It can also be used to make a posterior capsulorhexis.

“There is growing interest in primary posterior capsulorhexis, particularly in Europe where IOLs that are fixated by the anterior and posterior capsule are available. In addition, primary posterior capsulorhexis eliminates the potential for PCO,” Dr. Osher said.
The ApertureCTC creates a continuous thermal capsulotomy using a stainless steel ring that acts as a heat-conducting filament. The ring makes uniform contact with the anterior capsule, thereby eliminating the need for vacuum suction. It is still in preclinical development, but there is evidence that capsulotomies created with this device and with Zepto feature a capsulotomy edge that rolls back on itself. This finding would account for the smooth edge appearance and perhaps the increased strength reported for the Zepto capsulotomy, Dr. Packer said.

Based on his experience using these new devices, Dr. Packer commented, “I can say they definitely make capsulotomy quicker and easier compared with a manual technique, and I expect clinical trial data will establish that they are reliable tools for consistent capsulotomy. Their adoption, however, will depend on the cost.”

Lens removal technology and tools

Dr. Donnenfeld has been working with A.R.C. Laser, a German company that has a CE marked nanolaser for cataract surgery (Cetus). The technology features a YAG laser in the tip that is inserted into the eye. The laser has been in development by its inventor, Jack Dodick, MD, and A.R.C. Laser, but due to recent breakthroughs in technology, the device is now being used routinely in Germany by several surgeons, Dr. Donnenfeld said.

The laser beam strikes a titanium target, creating shockwaves that emulsify the crystalline lens. It minimizes thermal effects and uses a localized plasma that limits damage to the corneal endothelium and other ocular tissues, allowing for rapid visual recovery. In addition, it has a round, polished tip and disposable handpiece.

“This is very interesting technology and I was impressed to see how effective it was for removing up to grade 3+ nuclei,” said Dr. Donnenfeld, clinical professor of ophthalmology, New York University, New York, and founding partner, Ophthalmic Consultants of Long Island and Connecticut, Garden City, NY.

In 2016, Dr. Donnenfeld and colleagues published their research on the role of aberrant fluid infusion and adverse events in cataract surgery [Koplin RS, et al. J Cataract Refract Surg. 2016;42(8):1135-1140]. They observed that compression of the infusion sleeve at the corneal incision resulted in decentering of the phacoemulsification needle independent of the infusion sleeve and lead to attenuation of infusion volume down one side of the sleeve. Misdirected fluid exiting the opposite port then drove nuclear fragments through the trabecular meshwork into the vitreous.

“These retained nuclear fragments may be responsible for inflammation and cystoid macular edema after cataract surgery. We are working on the design of noncompressible sleeves that will prevent this problem,” he said.

Dr. Osher mentioned a unique torsional tip (MK tip, Charmant) designed by Japanese ophthalmologist, Makoto Kishimoto, MD, that could minimize free radical-induced endothelial damage by suppressing cavitations. The tip will be distributed by Aurora Surgical in the United States, but the launch date is not yet defined.

Diagnostics

Recently introduced devices for biometry include two instruments using swept-source optical coherence tomography (OCT)-the IOLMaster 700 from Zeiss and the Argos from Movu.

“This next generation of the IOLMaster has several attractive features and has increased the accuracy of IOL power calculations,” said Dr. Donnenfeld.

“It detects poor fixation, provides very accurate and reproducible keratometry measurements, and measures anterior chamber depth. It may also be helpful as a screening tool for macular disease by identifying some abnormalities that warrant patients being further evaluated with a macular OCT device.”

In addition, the recently released Aladdin combined biometer/topographer (Topcon) is integrating the Barrett Universal II, Barrett True-K, and Barrett Rx, formulas into its on-board IOL power calculation formulas. Oculus also introduced a new generation of its Scheimpflug imaging device-the Pentacam AXL-that integrates anterior segment tomography and axial length measurement while also taking into account posterior corneal astigmatism for more reliable toric IOL calculation.

“Toric IOL penetration has been stuck at around 7.5%, which is disappointing,” Dr. Osher said. “Growth has been limited by the inability to consistently deliver excellent outcomes for a group of patients who are paying out-of-pocket fees. We know failure to account for the posterior cornea is one of the missing links. The combination of better preoperative diagnostics and better power calculation formulas will allow us to nail the refractive target in a higher percentage of patients.”

Dr. Packer also commented on the importance of having preoperative diagnostic technology that can provide measurements of the posterior cornea.

The Alcon Cataract Refractive Diagnostics Technologies, comprised of the VERION Image Guided System and the ORA System with VerifEYe, has advantages for increasing surgical efficiency and minimizing errors. Still, the fact that VERION does not capture posterior cornea data probably plays a role in many cases where there is a mismatch between the intraoperative aberrometry measurement and the preoperative IOL calculations, he said.

“Users of the recently approved Holos IntraOp Wavefront Aberrometer (Clarity Medical Systems) will likely face the same challenge unless their preoperative calculations integrate posterior cornea data,” Dr. Packer said.

Availability of Holos as a second intraoperative aberrometer has been a long time coming, and Dr. Packer is looking forward to data from a study that investigates how its use improves the accuracy of refractive outcomes.

After some short-term experience with Holos, Dr. Osher described it as “fantastic technology.” Because the aberrometer attaches to the bottom of the operating microscope, he designed a set of shorter instruments for better clearance. This “No Fly Zone” instrument line is being developed by Bausch + Lomb.

Additional aids

More options for pupil expansion and capsule fixation are also emerging. A new version of the Malyugin Ring (MicroSurgical Technology) known as the Malyugin Ring 2.0 was introduced in 2016. It is a thinner and more flexible iteration of the device that can be inserted through a 2.0 mm incision.

Dr. Osher designed the new inserter and manipulator used for the Malyugin Ring 2.0. He also noted the recent release in the United States of the I-Ring Pupil Expander (Beaver Visitec International) and of the second-generation version of Ehud Assia’s pupil expander, the APX-200 (APX Ophthalmology), along with other pupil expansion devices internationally.

“This is really a hot area because a small pupil is a major risk factor for complications during cataract surgery,” Dr. Osher said.

Dr. Donnenfeld commented, “Both the I-Ring and the Malyugin Ring have been very effective for maintaining pupil dilation and improving the safety of cataract surgery, and I particularly like the I-Ring because I find it does not distort the pupil or tear the sphincter.”

Several new capsule fixation devices have recently become available outside of the United States. In this country, cataract surgeons may look forward to approval of the FortifEYE CTR from Bausch + Lomb. In addition, they will hopefully have access soon to the first FDA-approved iris prosthesis as enrollment has been completed in the HumanOptics FDA study and submission for approval is anticipated in the first quarter of 2017.

In 2016, Alcon Laboratories, in collaboration with TrueVision 3D Surgical, launched its heads-up digitally assisted vitreoretinal surgery platform (NGENUITY 3D Visualization System). The system includes a three-dimensional camera attached to the operating microscope optics and a flat panel, high-definition 4K OLED monitor on which the surgeon views a 3-D stereo image of the surgical field through passive glasses.

“This platform can really be used for all types of surgery and allows cataract surgeons to operate without looking through the microscope,” Dr. Donnenfeld said.

Dr. Osher noted that Beaver Visitec International will be introducing a drape that he designed. The product offers transparency over the fellow eye to eliminate claustrophobia, has less material for better patient comfort, and has less adhesive so that it is easier to remove.

MIGS

With the CyPass Micro-Stent (Alcon) receiving FDA approval in August 2016, surgeons now have a second option for combining MIGS with cataract surgery.

“We all knew there would be a merger of cataract and refractive surgery. Now, the merger between cataract and glaucoma surgery is sprinting ahead as the MIGS procedures come on-board,” said Dr. Osher.

Dr. Packer said that the CyPass approval is noteworthy for bringing another add-on to cataract surgery and because the results from COMPASS, the U.S. IDE clinical trial, provide definitive evidence that cataract surgery alone provides a durable IOP lowering effect. The 2-year results from COMPASS were published in October 2016 [Vold S, et al. Ophthalmology. 123(10):2103-2112]. The study randomized over 500 eyes 3:1 to the combination procedure or cataract surgery alone. Eligible patients had mean diurnal unmedicated IOP of 21 to 33 mm Hg. At 24 months in the group having cataract surgery alone, 59% of eyes were on no medication, mean IOP was reduced 5.4 mm Hg from baseline, and 60% achieved a ≥ 20% reduction in unmedicated IOP.

“There has been a body of accumulating data showing that cataract surgery reduces IOP,” said Dr. Packer. “Now we have proof of that benefit based on results from a rigorously designed, monitored, and audited large prospective clinical trial. Efficacy was significantly better in the combination group, but the benefit of cataract surgery on IOP lowering was not just a transient effect.”

Based on the study results, Dr. Packer said he would consider performing lens removal rather than a laser procedure or medication for managing elevated IOP in a patient who is a glaucoma suspect and presents with an early cataract or is interested in refractive lens exchange.

“The benefit of laser may not be that durable and compliance with medication can be poor. Lens removal may be the best option in terms of safety and effectiveness for patients with this stage of disease,” he said.

Office-based surgery

An article published in the April issue of Ophthalmology drew attention to the feasibility of office-based cataract surgery [Ianchulev T, et al. Ophthalmology. 2016;123(4):723-728]. The article reported on the experience at Kaiser Permanente Colorado where 21,500 cases were performed in minor procedure rooms at three centers from 2011 to 2014. During 2014, 93% of cataract surgeries occurred in the office setting.

Most of the procedures were performed under local anesthesia with an oral benzodiazepine but no intravenous sedation, and the visual acuity and safety results matched those reported for modern cataract surgery. There were no cases of endophthalmitis, capsular tears occurred in 0.55% of eyes, and the incidence of vitreous loss was 0.34%.

Dr. Packer was a coauthor of the paper and encouraged the Kaiser Permanente ophthalmologists to publish their experience. He noted that office-based and bilateral surgery are economically feasible at Kaiser because of the organization’s capitated payment structure. Outside that type of system, however, there are huge financial disincentives to office-based and bilateral simultaneous surgery considering the reimbursement schedules.

“That said, CMS is seeking public input on reimbursement for in-office cataract surgery. The costs are not zero, but certainly they are less than for procedures performed at a surgery center or hospital outpatient department,” Dr. Packer said.

He noted that the safety of modern cataract surgery and the possibility of performing it without intravenous sedation/anesthesia enable movement into the office-based setting. Introduction of a sublingual product for conscious sedation (IV Free MKO Melt, Imprimis Pharmaceuticals) and increased availability of disposable instruments may serve as driving factors.

“Storz has a complete line of disposable cataract instruments, and in September this year, Bausch + Lomb introduced an enhanced version of its Pinnacle 360 line of single-use instruments. While the Pinnacle 360 instruments are for vitreoretinal surgery, their availability speaks to the possibility of a cataract surgery line,” he said, adding that he is also aware of efforts toward developing a single-use phacoemulsification handpiece.

By increasing uptake of premium lenses, the approval of the Tecnis Symfony Extended Range of Vision and Symfony toric IOLs (Abbott) can also drive the movement of cataract surgery out of the surgery center, Dr. Packer suggested.

“If a patient is paying an out-of-pocket fee for presbyopia or astigmatism correction, which can range from $2,000 to $5,000 per eye, there is enough profit margin to cover the costs of operating in the office and sacrificing the loss of the $1,100 facility fee from Medicare or commercial insurance,” he explained. “The in-office procedure can also be appealing for patients because of its convenience and the opportunity to have surgery in a familiar setting, and surgeons who are comfortable doing so, can perform bilateral simultaneous surgery without having to accept a discounted fee for the second eye.”

Teaching tools

With all of the new developments occurring across the field, cataract surgeons face the need to keep up-to-date. Dr. Osher noted that tens of thousands of surgeons now have access to his Video Journal of Cataract and Refractive Surgery as a member benefit of various national professional organizations. Soon, the Video Journal will also be available to members of the Canadian Ophthalmological Society and Pan-American Association of Ophthalmology.
Dr. Osher is both thrilled and gratified to see how his innovative, cutting edge meeting, Cataract Surgery: Telling It Like It Is, has grown in both content and participation in the few years since its inception.

“In 2016, we had between 500 and 600 ophthalmologists registered and over 100 exhibitors for a program that lasted for 4 days from dawn to dusk,” he said.

“The 2017 meeting will feature a keynote address by Dr. Doug Koch and, as our International Guest of Honor, Dr. Richard Packard, who delivered the Binkhorst Medical Lecture at the ESCRS Congress in 2015. In addition, we have increased the number of didactic and wet labs to 30, reflecting attendee requests.”

Eric D. Donnenfeld, MD

E: ericdonnenfeld@gmail.com

Dr. Donnenfeld is a consultant to Abbott Medical Optics, AcuFocus, Alcon, Allergan, Aquesys, Bausch + Lomb, Beaver Visitec International, CRST, Glaukos, Novaliq, Omeros, Pfizer, and Shire Pharmaceuticals. He consults and has investment interests in Katena, Novabay Pharmaceuticals, PRN Pharmaceuticals, and RPS Diagnostics.

Robert H. Osher, MD

E: rhosher@cincinnatieye.com

Dr. Osher is a consultant to Alcon Laboratories, Bausch + Lomb, Beaver Visitec International, Carl Zeiss Meditec, Clarity Medical Systems, MicroSurgical Technology, Omeros, and the Video Journal of Cataract and Refractive Surgery.

Mark Packer, MD 

E: mark@markpackerconsulting.com

Dr. Packer is a consultant to Advanced Vision Science, Alcon, Allergan, Bausch + Lomb, Cassini BV, International Biomedical Devices, LensAR, Rayner, and STAAR Surgical, and he owns equity in Cassini BV, International Biomedical Devices, LensAR, and TrueVision.