PreserFlo microshunt may offer alternative to trabeculectomy
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Santen’s DE-128 microshunt, also known as PreserFlo, offers efficacious IOP lowering, an excellent safety profile and a lower complication rate compared with other filtration procedures, according to one surgeon.
Karsten Klabe, MD, head of the Research Institute for International Innovative Ophthalmologic Surgery in Düsseldorf, Germany, presented his first experiences with the PreserFlo at the virtual European Glaucoma Society congress.
“PreserFlo became my standard procedure for patients with open-angle glaucoma and high preoperative IOP and/or a low postoperative target pressure. It replaces nearly all cases of former trabeculectomy,” Klabe told Ocular Surgery News.
The device is currently available in Europe, and Santen has partnered with Glaukos to bring it to the United States. The FDA accepted the premarket approval application for the MIGS device in July 2020.
Short learning curve
The device is made from SIBS, a biocompatible, bioinert material that resists biodegradation. According to Santen, when the microshunt is implanted intraoperatively with application of mitomycin C at a concentration between 0.2 mg/mL to 0.4 mg/mL, it reduces IOP in patients with primary open-angle glaucoma.
In a multicenter study, the device reduced mean diurnal IOP from 21.1 mm Hg to 14.2 mm Hg at month 12 compared with a reduction from 21.1 mm Hg to 11.2 mm Hg in a standard of care trabeculectomy group.
“If you feel comfortable with trabeculectomy, the learning curve is very short. The postoperative IOP is very consistent, usually between 10 mm Hg and 12 mm Hg from day 1. Early complications like choroidal detachment, bleb leakage, and flat or shallow anterior chamber are significantly lower than in trabeculectomy,” Klabe said.
Different bleb
The different architecture of the bleb, which is smoother and more posterior, seems to lead to a lower risk for fibrosis and ocular surface issues, as well as late-onset bleb complications, Klabe said.
Precise preparation of the scleral tunnel for the microshunt position and a tension-free readaptation of Tenon and conjunctiva are key issues to ensure free flow at the conclusion of the procedure, he said.
“I add an injection of Healon (sodium hyaluronate, Johnson & Johnson Vision), between 0.1 mL to 0.2 mL, under the reattached Tenon to prevent contact between the implant and the Tenon. I prefer to suture Tenon and conjunctiva separately, which makes it easier to achieve a watertight wound closure,” he said.
Finally, before closing the Tenon and conjunctiva, Klabe checks for a “perfect flow,” frequent small fluid bubbles after pressurizing the globe, to ensure procedure success.
- References:
- FDA accepts premarket approval application for DE-128. www.healio.com/news/ophthalmology/20200707/fda-accepts-premarket-approval-application-for-de128. Published July 7, 2020. Accessed March 1, 2021.
- Santen plans entry in US glaucoma market. www.healio.com/news/ophthalmology/20200114/santen-plans-entry-in-us-glaucoma-market. Published Jan. 14, 2020. Accessed March 1, 2021.
- For more information:
- Karsten Klabe, MD, can be reached at Breyer Kaymak Klabe Augenchirurgie, Martin Luther Platz 22, 40212 Düsseldorf, Germany; email: k.klabe@augenchirurgie.clinic.
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Klabe K, et al. PreserFlo Microshunt – The better trabeculectomy? First experiences with a new microshunt in glaucoma surgery. Presented at: European Glaucoma Society congress; Dec. 12-13, 2020 (virtual meeting).
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