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XEN Gel Stent in Pseudoexfoliative Glaucoma

2-Year Results of a Prospective Evaluation

Gillmann, Kevin MBBS, FEBOphth, MArch*; Bravetti, Giorgio E. MD*; Mermoud, André MD*; Rao, Harsha L. MD, PhD; Mansouri, Kaweh MD, MPH*,‡

doi: 10.1097/IJG.0000000000001295
Original Studies
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Précis: This study confirms the safety and efficacy of XEN gel stents in the management of pseudoexfoliative glaucoma 2 years after implantation, with success rates similar to primary open-angle glaucoma regardless of the definition of success.

Purpose: To compare the long-term safety and efficacy of XEN gel implant surgery (Allergan Inc., Irvine, CA) in patients with pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG).

Setting: Prospective, interventional study in a tertiary glaucoma center.

Methods: A total of 110 eyes of 85 patients with POAG (57 eyes) or PEXG (53 eyes) and uncontrolled intraocular pressure (IOP) despite medical treatment underwent combined XEN+cataract surgery or standalone XEN surgery. Mean IOP, mean number of medications, needling rates, and incidence of adverse effects were compared between the 2 groups. Complete surgical success was defined as an unmedicated IOP≤12, 15, 16, or 18 mm Hg at 2 years, both with and without a 20% reduction from baseline.

Results: Combined XEN+cataract surgery was performed in 72% of POAG and 76% of PEXG eyes (P=0.67), the remainder underwent standalone XEN surgery. Patient characteristics were similar between the 2 groups except for older age for the patients with PEXG (78.5±8.5 vs. 71.3±8.7 y; P<0.005). Mean medicated IOP were 19.8±5.8 mm Hg (POAG) versus 19.8±8.2 mm Hg (PEXG) at baseline (P=0.98), and 14.5±3.6 mm Hg (−26.8%) versus 14.2±3.8 mm Hg (−28.3%), respectively, at 2 years (P=0.75). Mean medications concomitantly dropped from 1.9±1.6 (POAG) versus 2.0±1.3 (PEXG) to 0.6±0.9 versus 0.4±0.7, respectively (P=0.29). Using the 16 mm Hg threshold, 51.4% (POAG) versus 57.1% (PEXG) eyes achieved complete success (P=0.70) at 2 years. The difference in success rates between the 2 groups was not statistically significant under any of the definitions of success. By 24 months, needling was performed in 42.8% (POAG) and 43.2% (PEXG) (P=0.64), with an average time to needling of 162.8 and 134.9 days, respectively (P=0.46). The rates of adverse effects were 30.6% (POAG) and 36.4% (PEXG) (P=0.66), and additional glaucoma surgeries were carried out in 14.3% (POAG) versus 15.9% (PEXG) (P=0.89).

Conclusions: The XEN gel implant as a standalone or combined procedure demonstrated similar efficacy and safety results in PEXG and POAG eyes.

*Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, Switzerland

Department of Ophthalmology, University of Colorado School of Medicine, Denver, CO

Narayana Nethralaya, Hulimavu, Bangalore, India

Supported in part by the Swiss Glaucoma Research Foundation, Lausanne, Switzerland.

K.M.: Santen (Consultant), Sensimed (Consultant), Topcon (Sponsor), Alcon (Sponsor), Allergan (Sponsor, Optovue (Consultant), ImplanData (Consultant). A.M.: Alcon (Sponsor), Allergan (Sponsor), Santen (Consultant), Swiss Advanced Vision (Consultant), Rheon Medical (Consultant), Glaukos (Consultant), Diopsys Inc. (Consultant), DeepCube (Consultant). H.L.R.: Allergan (Consultant), Carl-Zeiss Meditec (Consultant), Santen (Consultant). The remaining authors declare no conflict of interest.

Reprints: Kaweh Mansouri, MD, MPH, Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne 1006, Switzerland (e-mail: kwmansouri@gmail.com).

Received March 11, 2019

Accepted May 22, 2019

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