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Long-term results of glaucoma micro-stent encouraging
Stable reduction of IOP and medications allows long-term vision preservation and improved quality of life.
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Implantation of the CyPass micro-stent provides long-term control of IOP and a significant reduction in medication, according to one surgeon.
“The effect is durable. I have the most patients with 7 years of follow-up, and reduction of IOP is on average the same that was achieved a few days after the operation. The reduction of medications is as well consistent, from three to four before to one or two after, or even no medications at all,” Magda Rau, MD, OSN Europe Edition Associate Editor, told Ocular Surgery News.
Rau’s first experience with the CyPass (Transcend Medical) was in 2009. She participated in a multicenter European study in which, at 3 years in her patient group, IOP was reduced to less than 21 mm Hg in 100% of patients, to less than 18 mm Hg in 80% of patients and to less than 15 mm Hg in 60% of patients. The good results encouraged her to continue with the device and include it in her daily practice.
The CyPass seems to have overcome limitations of previous micro-stents, which ceased to be effective after a while due to fibrotic encapsulation. In the 150 patients implanted by Rau, adherence of the iris, resulting in partial obstruction of the lumen, was observed in only a couple of cases and was easily resolved with a YAG laser.
“The CyPass is relatively large in comparison with other stents. It has a length of 6.3 mm, and the inner diameter is 0.3 mm. It also has holes along the entire surface, which enhances the aqueous outflow. We even had cases in which the CyPass disappeared in the suprachoroidal space and still surprisingly maintained its IOP-lowering function; otherwise the obstruction causes immediate elevation of pressure,” Rau said.
Alone or in combination
The combination of CyPass with cataract surgery achieves the best results and is better accepted by patients, Rau said.
“When you propose it as an adjunctive procedure to cataract surgery, patients accept it very easily and are happy to be offered the chance to treat glaucoma at the same time. When you propose it alone, the impact is completely different. Patients are afraid of surgery and believe that because they don’t have symptoms, the disease is not there,” Rau said.
However, CyPass alone is an option, and several standalone implantations have been successfully completed.
“It is an option for patients in whom, despite maximal therapy, we could observe the progression of glaucomatous neuropathy and visual fields defects and worsening on OCT of the retinal nerve fiber layer,” Rau said. “Because of the noninvasive, safe characteristics of the CyPass, patients also with severe glaucoma progression with only minimal remaining visual fields may benefit. If a trabeculectomy were performed at this advanced stage of glaucomatous disease, it is possible that the last of the patient’s remaining visual field would be lost. Glaucoma is a progressive disease, and if IOP rises over time, we can perform trabeculectomy on the virgin area because the CyPass procedure spares the conjunctiva and the sclera.”
The device addresses the supraciliary space, which has a high ability of absorption. The effect is enhanced by the negative pressure gradient, a difference of 3 mm Hg to 4 mm Hg between the suprachoroidal space and the anterior chamber.
“This provides a driving force for the aqueous outflow to the suprachoroidal space,” Rau said.
Indications
The CyPass is indicated for patients with open-angle glaucoma and a rather wide angle, Shaffer 3 or 4, because this space is needed for implantation, Rau said.
“Provided that this condition is satisfied, I offer the CyPass to patients who are on more than three medications and suffer from side effects, general or local; to those who feel their life quality is poor because of the drops; and to those who have problems with compliance. In my clinic, this procedure has almost replaced trabeculectomy,” she said.
In a 65-year-old woman with significant visual field changes leading to loss of the temporal quadrant, Rau implanted the CyPass. The visual field improved, as shown by perimetry. The retinal nerve fiber layer showed improvement as well on OCT.
“I think this is because the CyPass leads to constant reduction of intraocular pressure, unlike drops that cause fluctuations and peaks of pressure elevation during the night. I observed this phenomenon also in other patients. Constant reduction makes quite a difference, and nerve fibers that are not completely damaged can recover,” Rau said.
A worthwhile investment
According to Rau, micro-stent surgery should gain an increasingly important role in the management of open-angle glaucoma in the future.
“Now that we have proved that the results are good and last over time, we can easily demonstrate that the procedure is also cost-effective. The price of the CyPass device is around €1,000, which is really low for obtaining stable reduction of IOP and medications,” she said.
Yet, there is still a reluctance to include micro-stent surgery in public and private health insurance plans.
“If you compare the cost of CyPass, which is a single implantation that lasts for years, with the cost of anti-VEGF injections, on which all governments and private insurances have invested, it is difficult to understand the reason of this reluctance. The price of one intravitreal injection is €1,000 to €1,600, plus the cost of the procedure, multiplied by on average six times per year per patient for many years. It is an enormous investment. With CyPass, we could achieve so much with so little, save visual acuity to so many people for a very long time, for a lifetime in most cases. We have to convince our governments and insurance companies that the investment is definitely worthwhile,” Rau said. – by Michela Cimberle
- For more information:
- Magda Rau, MD, can be reached at Augenklinik Cham, 93413 Cham, Bavaria, Germany; email: info@augenklinik-cham.de.
Disclosure: Rau reports no relevant financial disclosures.