Outcomes of Deep Sclerectomy following Failed XEN Gel Stent Implantation in Open-Angle Glaucoma: A Prospective Study

Background: The purpose of this study is to evaluate the outcome of deep sclerectomy (DS) as a secondary procedure following failed ab-interno XEN gel stent implantation in patients with open-angle glaucoma. Methods: Prospective, single-center, non-randomized, interventional study. Consecutive eyes that underwent mitomycin C (MMC) augmented XEN gel stent surgery, with uncontrolled intraocular pressure (IOP) or signs of disease progression, were included to undergo MMC-augmented DS. Primary efficacy outcome was surgical success, defined as complete when the unmedicated IOP was 12 mmHg or less, or 15 mmHg or less and 20% lower than at the timing of XEN failure and defined as qualified when the IOP fulfilled the same conditions with fewer medications than before deep sclerectomy. Secondary measures were mean reduction in IOP and in the number of medications, and the rates of complications. Results: Seventeen eyes were enrolled with a mean age of 72.1 ± 8.2 years (66.7% women). The mean follow-up was 20.1 ± 4.9 months, with more than 12-month data available from 15 eyes. Following DS, IOP decreased significantly from 22.6 ± 5.3 mmHg to 12.3 ± 5.5 (45.6%; p < 0.001). Antiglaucoma medications dropped from 1.1 ± 0.9 to 0.3 ± 0.7. Complete success was obtained in 40% of eyes using the threshold of 12 mmHg or less and a 20% decrease of IOP, and in 60% using the 15 mmHg or less threshold. Adverse events were observed in 20% of eyes (bleb leakage (13.3%); hypotony (6.7%)). No cases of choroidal detachment or hypotony maculopathy were reported. Conclusions: Failed XEN gel stent implantation does not seem to negatively affect the safety and efficacy of subsequent deep sclerectomy surgery.

[1]  A. Mermoud,et al.  XEN-augmented Baerveldt drainage device implantation in refractory glaucoma: 1-year outcomes , 2020, Graefe's Archive for Clinical and Experimental Ophthalmology.

[2]  L. Abegão Pinto,et al.  XEN‐augmented Baerveldt surgical success rate and comparison with the Ahmed Valve , 2020, Acta ophthalmologica.

[3]  A. Mermoud,et al.  Outcome and Complications of Combined Modified Deep Sclerectomy and Trabeculectomy for Surgical Management of Glaucoma: A Pilot Study , 2020, Clinical ophthalmology.

[4]  A. Mermoud,et al.  Impact of Phacoemulsification Combined with XEN Gel Stent Implantation on Corneal Endothelial Cell Density: 2-Year Results. , 2020 .

[5]  Gideon Nkrumah,et al.  Real-World Retrospective Consecutive Study of Ab Interno XEN 45 Gel Stent Implant with Mitomycin C in Black and Afro-Latino Patients with Glaucoma: 40% Required Secondary Glaucoma Surgery at 1 Year , 2019, Middle East African journal of ophthalmology.

[6]  R. Widder,et al.  Intraocular Degradation of XEN45 Gel Stent Three Years After Its Implantation. , 2019, Journal of glaucoma.

[7]  K. Mansouri,et al.  Delayed Obstruction of XEN Gel Stent by Cell Debris in Primary Open-angle Glaucoma: A New Insight into the Pathophysiology of Filtration Device Failure , 2019, Journal of current glaucoma practice.

[8]  A. Mermoud,et al.  Two-Year Outcomes of XEN Gel Stent Surgery in Patients with Open-Angle Glaucoma. , 2019, Ophthalmology. Glaucoma.

[9]  A. Mermoud,et al.  XEN Gel Stent in Pseudoexfoliative Glaucoma: 2-Year Results of a Prospective Evaluation , 2019, Journal of glaucoma.

[10]  S. Bhartiya,et al.  Revisiting Results of Conventional Surgery: Trabeculectomy, Glaucoma Drainage Devices, and Deep Sclerectomy in the Era of MIGS , 2019, Journal of current glaucoma practice.

[11]  A. Chaoubah,et al.  Use of a Collagen Matrix Implant as an Adjuvant in Combined Surgery Involving Phacoemulsification and Nonpenetrating Deep Sclerectomy , 2019, Journal of glaucoma.

[12]  A. Mostafaei,et al.  Comparison of the effect of mitomycin C and bevacizumab–methylcellulose mixture on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure (a clinical trial study) , 2019, International Ophthalmology.

[13]  A. Mermoud,et al.  Anterior Chamber XEN Gel Stent Movements: The Impact on Corneal Endothelial Cell Density. , 2019, Journal of glaucoma.

[14]  A. Mermoud,et al.  Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma , 2018, Journal of glaucoma.

[15]  A. Elkarmouty,et al.  Trabeculectomy Following Failed Ab Interno Gelatin Microstent: Case Series , 2018, Journal of glaucoma.

[16]  A. Mermoud,et al.  Chronic Intraocular Inflammation as a Risk Factor for XEN Gel Stent Occlusion: A Case of Microscopic Examination of a Fibrin-obstructed XEN Stent , 2018, Journal of glaucoma.

[17]  D. Laroche,et al.  Baerveldt Attached to XEN: A New Technique to Manage Failed XEN Glaucoma Surgery , 2018, Journal of glaucoma.

[18]  M. Harju,et al.  Long‐term results of deep sclerectomy in normal‐tension glaucoma , 2018, Acta ophthalmologica.

[19]  J. Kalenak Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months. , 2018, American journal of ophthalmology.

[20]  A. Mermoud,et al.  XEN Gel Implant: a new surgical approach in glaucoma , 2018, Expert review of medical devices.

[21]  A. Mermoud,et al.  Prospective Evaluation of Standalone XEN Gel Implant and Combined Phacoemulsification-XEN Gel Implant Surgery: 1-Year Results , 2017, Journal of glaucoma.

[22]  Y. Duh,et al.  Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months. , 2017, American journal of ophthalmology.

[23]  M. Schlenker,et al.  Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. , 2017, Ophthalmology.

[24]  M. Ceccarelli,et al.  Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis , 2017, PloS one.

[25]  A. Mermoud,et al.  XEN-augmented Baerveldt: A New Surgical Technique for Refractory Glaucoma , 2016, Journal of glaucoma.

[26]  I. Ahmed,et al.  Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma. , 2015, Investigative ophthalmology & visual science.

[27]  R. Lewis Ab interno approach to the subconjunctival space using a collagen glaucoma stent. , 2014, Journal of cataract and refractive surgery.

[28]  F. Medeiros,et al.  The pathophysiology and treatment of glaucoma: a review. , 2014, JAMA.

[29]  N. Stergiopulos,et al.  A new adjustable glaucoma drainage device. , 2014, Investigative ophthalmology & visual science.

[30]  C. Bunce,et al.  Non-penetrating filtration surgery versus trabeculectomy for open-angle glaucoma. , 2014, The Cochrane database of systematic reviews.

[31]  I. Floriani,et al.  Efficacy and safety of trabeculectomy vs nonpenetrating surgical procedures: a systematic review and meta-analysis. , 2013, JAMA ophthalmology.

[32]  A. Mermoud,et al.  Deep sclerectomy. , 2012, Developments in ophthalmology.

[33]  A. Gupta,et al.  Primary Phakic Deep Sclerectomy Augmented With Mitomycin C: Long-term Outcomes , 2011, Journal of glaucoma.

[34]  N. Cassoux,et al.  Deep sclerectomy and trabeculectomy in uveitic glaucoma , 2010, Eye.

[35]  P. Denis,et al.  Ultrasound Biomicroscopy and Optical Coherence Tomography Imaging of Filtering Blebs after Deep Sclerectomy with New Collagen Implant , 2009, European journal of ophthalmology.

[36]  O. Schwenn,et al.  [Deep sclerectomy using a hyaluronate implant versus trabeculectomy. A comparison of two glaucoma operations using mitomycin C]. , 2004, Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft.

[37]  A. Mermoud,et al.  Long‐term results of deep sclerectomy with collagen implant , 2003, Journal of cataract and refractive surgery.

[38]  O. Schwenn,et al.  Tiefe Sklerektomie mit Hyaluronatimplantat vs. Trabekulektomie , 2004, Der Ophthalmologe.

[39]  A. Rossier,et al.  Aqueous dynamic and histological findings after deep sclerectomy with collagen implant in an animal model , 2003, The British journal of ophthalmology.

[40]  G. Krieglstein,et al.  Ultrasound biomicroscopy images: long-term results after deep sclerectomy with collagen implant , 2002, Graefe's Archive for Clinical and Experimental Ophthalmology.

[41]  A. Mermoud,et al.  Deep Sclerectomy With Collagen Implant in One Eye Compared With Trabeculectomy in the Other Eye of the Same Patient , 2002, Journal of glaucoma.

[42]  M. Johnson,et al.  How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. , 2001, Journal of glaucoma.

[43]  M. Helal,et al.  Nonpenetrating deep sclerectomy versus trabeculectomy in bilateral primary open-angle glaucoma. , 2000 .

[44]  P. Khaw,et al.  Anterior chamber flare after trabeculectomy and after phacoemulsification , 2000, The British journal of ophthalmology.

[45]  A. Mermoud,et al.  Comparison of deep sclerectomy with collagen implant and trabeculectomy in open-angle glaucoma. , 1999, Journal of cataract and refractive surgery.

[46]  A. Mermoud,et al.  Post-operative inflammation following deep sclerectomy with collagen implant versus standard trabeculectomy , 1998, Graefe's Archive for Clinical and Experimental Ophthalmology.