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Francisco Millan, Maria E. Reveron, Lilian Gonzalez, Miguel Siso, Carelys Suescum, Gary D Novack, Susan S Lee, Vanessa Vera; Evaluation of the XEN45 Gel Stent in Patients with Primary Angle Closure Glaucoma. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2113.
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© ARVO (1962-2015); The Authors (2016-present)
The XEN45 Gel Stent has been evaluated in patients with open angle glaucoma. In this report, we sought to evaluate the use of this device in patients with primary angle closure glaucoma (PACG). Based upon its small size, soft polymer composition, and anterior chamber placement, there is reason to believe it might be useful as a PACG therapeutic option.
This was a retrospective review of XEN surgical experience between February 2014 and May 2016 of 3 ophthalmologists in South America. Preoperative evaluations, including measurement of intraocular pressure (IOP) and enumeration of medications was performed. Post-operative visits were consistent with standard of care, and typically included 1 day, 1 and 2 weeks, 1, 2, 3, 6, 9 and 12 months. Presented are data available as of early November 2016.
Implanted were 15 eyes of 13 patients, and with the exception of 1 XEN solo procedure, the majority were considered mixed mechanism glaucoma due to XEN placement immediately after cataract extraction in PACG patients. The population consisted of Hispanic females with a mean age of 62.8 ± 10.6 years (range 43 - 80). All received pre-operative mitomycin-c and post-operative dexamethasone.From a mean pre-operative medicated IOP of 19.5 ± 2.9 mmHg, mean IOP at the first post-operative day decreased to 10.8 ± 6.1 (-8.7 mmHg) and 11.2 ± 3.5 at 1 week (-8.5 mm Hg). Mean IOP remained decreased, with the 8 eyes with data at 12 months having a mean IOP of 13.0 ± 2.6 (-6.5 mmHg). The proportion of the 15 eyes experiencing a decrease in IOP of 20% or more was 100% (8/8) at Month 12. The mean number of medications decreased from 3.3 ± 1.2 pre-operatively to 0.9 ± 1.1 at 12 months. Only one patient was considered an efficacy failure (Month 12), requiring an additional glaucoma surgical intervention.There were 3 reports of needling procedures performed in 2 eyes. Transient post-operative hyphema (microscopic, 1 eye; Grade I, 2 eyes) was the most common post-operative complication, followed by cystoid macular edema (1 eye post combined surgery).
In this retrospective evaluation of patients with PACG, the XEN gel stent was safe and effective in lowering the IOP ≥20% in the majority of patients at 12 months and medication use from baseline was reduced by approximately two-thirds. Further clinical studies are indicated to evaluate the safety and efficacy of the XEN gel stent in managing patients with PACG.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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