EyeWorld India September 2019 Issue

EWAP SEPTEMBER 2019 33 SECONDARY FEATURE glaucoma management without concurrent cataract surgery,” the researchers wrote. Adding to the MIGS evidence Beyond the results themselves, the COMPARE study provides yet more evidence to help comprehensive ophthalmologists in their decision-making, surgeons said. “Having multiple MIGS procedures available to us means that we need better comparative data in order to decide which procedure to use and when,” said COMPARE co-study author David F. Chang, MD. “For canal-based MIGS procedures, all of the FDA clinical trials compared the stent when used concomitantly with phaco to phaco alone. This “>Žià ˆÌ `ˆvwVÕÌ Ìœ Vœ“«>Ài ̅i Ài>̈Ûi ivwV>VÞ œv ̅iÃi `ˆvviÀi˜Ì devices. The COMPARE trial is therefore important because it is a prospective randomized trial comparing the Hydrus to two ‘generation one’ iStents in eyes without simultaneous phaco. Although so-called standalone implantation of a canal-based stent is off-label, the advantage of this trial design is that any confounding effect of phaco is avoided.” Although the study’s lack of phaco affects how surgeons may perceive the results, Constance Okeke, MD, said there is still value. “One can still extrapolate a viiˆ˜} œv Vœ˜w`i˜Vi ̅>Ì Ì…iÀi½Ã ivwV>VÞ ˆ˜ ̅i - «œÀ̈œ˜ œv ̅i procedure,” she said. The value of head-to-head comparison data from trials like COMPARE and the recently updated HORIZON results are of great use to glaucoma surgeons, said Ike Ahmed, MD, who was involved with both studies. “Unlike other areas of ophthalmology, glaucoma is a chronic condition, and the longer picture is very much a measure of success. It’s valuable information in terms of clinical metrics and also potential events and safety,” he said. In lieu of the CyPass (Alcon) recall last year, safety data are crucial for any device-related studies, Dr. Ahmed added. The real-world link and more studies needed How can surgeons begin to apply study results in the OR if COMPARE does not mimic how they must use the devices—or if the full breadth of studies needed are not yet available? Dr. Okeke encourages surgeons to take a hard look at their own data and come up with some conclusions. “Those areas can help us with decision- making when we don’t have clinical trials,” she said. She has reviewed self-driven data and has found that in her hands a certain approach works most effectively in certain patients. For instance, she has reviewed information on her patients and found very good outcomes with the use of goniotomy with the Trabectome (NeoMedix), done in combination with cataract surgery or as a standalone, especially in pseudoexfoliation glaucoma. Other times, based on her self-data review, she has steered away from using a certain procedure that she previously thought was working well, or changed intra- or postoperative procedures to get better outcomes. Even though the iStent did not have stronger results in COMPARE versus the Hydrus, it still can have its advantages, Dr. Okeke said. She pointed to a fairly easy learning curve and a preference for the iStent in certain eyes. “The Hydrus takes up more space in the canal. If one needs an additional procedure, there may be more room with the iStent than the Hydrus,” she said. Dr. Okeke also sees a role for goniotomy and canaloplasty, both of which can be used with or without cataract surgery and can be performed on patients with a variety of glaucoma severity. “There’s a little more versatility, and with these procedures, there’s some differences in reimbursement,” she said. A larger number of head-to- head MIGS comparisons will be important going forward, Dr. Okeke said. A comparison of MIGS devices or procedures that work similarly would be particularly valuable and help target patient selection and glaucoma severity better, she said. A broader understanding of which MIGS approaches could help avoid trabeculectomy— even though the latter is still a viable option for many patients—could also help guide surgeons, Dr. Ahmed said. “For example, the HORIZON trial recently showed Hydrus achieving a statistically È}˜ˆwV>˜Ì Ài`ÕV̈œ˜ ˆ˜ “œÀi major incisional glaucoma surgery at 3 years compared to cataract surgery alone, which is encouraging for a MIGS device,” he said. Additionally, targeting surgical approaches that reduce reliance on medications is often an important outcome to patients, he said. More data should come out from the COMPARE trial eventually. At the American Glaucoma Society meeting earlier this year, 24-month data from COMPARE showed superior reduction in medication burden with the Hydrus, and fewer patients required >``ˆÌˆœ˜> wÌiÀˆ˜} «ÀœVi`ÕÀià to obtain adequate IOP control. EWAP Editors’ note: Dr. Ahmed practices at the University of 6QTQPVQ CPF JCU ƂPCPEKCN KPVGTGUVU KP +XCPVKU CPF )NCWMQU &T %JCPI KU KP RTKXCVG RTCEVKEG KP .QU #NVQU %CNKHQTPKC CPF JCU ƂPCPEKCN KPVGTGUVU KP +XCPVKU &T 1MGMG RTCEVKEGU CV 8KTIKPKC '[G %QPUWNVCPVU 0QTHQNM 8KTIKPKC CPF JCU ƂPCPEKCN KPVGTGUVU KP 'NNGZ )NCWMQU 0GQ/GFKZ CPF 5KIJV 5EKGPEGU Reference 1. Ahmed IIK, et al. A prospective randomized trial comparing Hydrus and iStent micro-invasive glaucoma surgery implants for standalone treatment of open-angle glaucoma: The COMPARE Study. Ophthalmol. 2019 . Epub ahead of print. iStent