Prospective Evaluation of XEN Gel Implant in Eyes with Pseudoexfoliative Glaucoma

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Abstract

Purpose:

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

Setting:

Prospective, interventional study in a tertiary glaucoma center.

Methods:

Fifty-seven eyes (43 patients) with POAG and 53 eyes (42 patients) with PEXG with uncontrolled intraocular pressure (IOP) despite medical treatment underwent combined XEN+cataract surgery or standalone XEN surgery. Mean IOP, mean number of medications at 1-year follow-up, needling rates, and incidence of adverse effects (AE) were analyzed. Complete success, defined as an IOP lower than 16▒mmHg without medications at 1 year, was also analyzed.

Results:

Combined XEN+cataract surgery was performed in 72% of POAG and 75% of PEXG eyes (P=0.674), the remainder underwent standalone XEN surgery. Patient characteristics were similar between the two groups except for higher age for the PEXG patients (78.5±8.5 vs. 71.3± 8.7▒y; P<0.001). Mean medicated IOP was 19.8±5.8 (POAG) and 19.7±8.2 (PEXG) at baseline (P=0.98) and 13.9±4.6 (−29.8%) and 13.6±4.3▒mmHg (−31%) at 1 year (P=0.87), respectively (P<0.01). Mean medications dropped from 1.9±1.6 (POAG) and 2.0±1.3 (PEXG) preoperatively to 0.4±0.8 and 0.5±0.8, respectively at 1 year (P<0.001). 42% (POAG) and 63% (PEXG) eyes achieved complete success (P=0.06) at 1 year. Needling was done in 36.8% (POAG) versus 37.7% (PEXG) (P=0.923).

Conclusions:

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

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