Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer, Herbert A.; Sng, Chelvin C. A.; Vera, Vanessa; Lenzhofer, Markus; Barton, Keith; Stalmans, Ingeborg; Ansari, Ejaz; Au, Leon; Dick, H. Burkhard; Cadarso, L.; Fea, Antonio; Hengerer, Fritz H.; Höh, H.; Lavín-Dapena, Cosme; Ks, Lim; Marchini, Giorgio; Masood, Imran; Mossböck, Georg; Nagar, Madhu; Nardi, Marco; Rękas, Marek; Shaarawy, Tarek; Teus, Miguel A.; Vass, Clemens

doi:10.1007/s00417-019-04251-z

Cited by 173 publications

(246 citation statements)

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“…Overall success rates and efficacy (IOP and number of medications) results are comparable to the recently published APEX study (Reitsamer et al. ). There are no data yet published establishing whether a deep or superficial implantation in the conjunctiva is advantageous for an efficacious patient outcome after XEN‐GGM implantation.…”

Section: Discussionsupporting

confidence: 83%

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation

Lenzhofer

Strohmaier

Sperl

et al. 2019

Acta Ophthalmologica

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Purpose: The outer stent lumen can be located either deeper (in or under Tenon's layer) or more superficially in the conjunctival stroma after the transscleral XEN Glaucoma Gel Microstent (XEN-GGM; Allergan Plc., USA) implantation. The present study aimed to investigate the effect of the postoperative conjunctival implant position on surgical success and intraocular pressure (IOP) after XEN-GGM. Methods: Prospective data from 66 consecutive open-angle glaucoma eyes of 54 patients were collected preoperatively and 1 and 2 weeks, and 1, 6 and 12 months postoperatively. The layer of implantation was determined in the first month postoperatively as intra-and subtenon or intraconjunctival depending on the location of the outer lumen of the stent in OCT (Visante OCT; Zeiss, Germany). Primary outcome measures were differences in relative IOP reduction at 12 months between the two groups. Further, complete and qualified surgical success, number of secondary needlings and number of IOP-lowering medications and absolute IOP were assessed. Results: Relative IOP reduction was higher in intra-and subtenon group (n = 37/ 66, 56%) at week 1 (À54% versus À19%, p < 0.001), week 2 (À39% versus À21%, p = 0.02), month 1 (À42% versus À28%, p = 0.035) and month 12 (À39% versus À24%, p = 0.024). The mean absolute IOP was lower in intra-and subtenon group at week 1 (10.8 [95%CI,.0] mmHg, p < 0.001) and months 12 (13.9 [95%CI,] mmHg, p = 0.041). At month 6, a lower burden for IOP-lowering medication was shown for the intra-and subtenon group (0.2 AE 0.5 versus 1.0 AE 1.1, p = 0.034). The mean number of secondary needlings, which were done in 47/66 (71%) of the eyes, was lower in the intra-and subtenon group in the first year (1.9 AE 1.7 versus 1.2 AE 1.2, p = 0.03). Qualified surgical success was higher in the intra-and subtenon group (90% versus 61%, p = 0.01) after 1 year. Conclusion: The present study demonstrates a higher efficacy achieved with lower secondary needling rates in deeper implant positions in conjunctiva after XEN-GGM.

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Section: Discussionsupporting

confidence: 83%

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation

Lenzhofer

Strohmaier

Sperl

et al. 2019

Acta Ophthalmologica

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“…Data published thus far support the Xen implant being a safe and effective approach to lowering IOP and reducing drop dependency in patients with glaucoma [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. Although these reports show complications rates to be lower than those associated with traditional glaucoma surgery, it is standardly accepted that a proportion of eyes will require bleb needling in the post-operative period and that despite this some implants will fail due to progressive scarring of the conjunctiva around the stent opening that is unresponsive to slit lamp needling and antimetabolite injections [12].…”

Section: Introductionmentioning

confidence: 94%

Technique of Xen Implant Revision Surgery and the Surgical Outcomes: A Retrospective Interventional Case Series

Linton

2020

Ophthalmol Ther

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Purpose: The XenÒ Gel Stent (Allergan, Irvine, CA, USA) is a minimally invasive glaucoma surgery device implanted to reduce intra-ocular pressure (IOP) in glaucoma. The stents can fail to drain post-operatively due to scarring of the conjunctiva around the stent opening. Data on the success rates of revision surgery in patients with Xen stent failure are scarce. We present the first detailed report of the steps, outcomes and complications of Xen revision surgery with 12 months of follow-up data. Methods: We share our experiences on the circumstances in which to perform Xen revision surgery, the steps of the surgery and the results of a retrospective interventional case series of all Xen revisions performed at a single centre from 2013 to 2018. Results: A total of 151 Xen implants were inserted into eyes at our tertiary centre during the study period, of which 21 eyes (patients) underwent revision surgery. Mean pre-operative Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11771391.

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“…The XEN microstent is designed to bypass the transtrabecular out ow pathway whereby reducing IOP. Since its initial description, a number of reports have been published on the e cacy and safety pro le of the XEN microstent for the treatment of POAG [21,18,22]. In summary, implantation of the XEN microstent can signi cantly reduce IOP and the amount of IOP-lowering eye drops applied, resulting in acceptable success rates in POAG after 12 and 24 months.…”

Section: Discussionmentioning

confidence: 99%

“…In summary, implantation of the XEN microstent can signi cantly reduce IOP and the amount of IOP-lowering eye drops applied, resulting in acceptable success rates in POAG after 12 and 24 months. Reitsamer and colleagues already showed in their one and two-year multicenter study (APEX study) that IOP and required medication can be reduced effectively by implantation of the XEN microstent either alone or in combination with phacoemulsi cation and posterior chamber lens implantation [21] Some groups even reported on achieving lower mean postoperative IOP values of around 12 mmHg when starting from a lower initial mean level at baseline before surgery [23].…”

Section: Discussionmentioning

confidence: 99%

Comparison of the effectiveness of the XEN microstent in the treatment of different types of glaucoma

Schargus

Teilig

Rehák

et al. 2020

Preprint

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Abstract PurposeThe aim of this study was to compare the efficacy and safety profile of the XEN-microstent in different types of primary and secondary open angle glaucoma. MethodsThe XEN microstent was implanted in patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), pseudoexfoliation glaucoma (PEX) and secondary glaucoma (Sec.Gl). The intraocular pressure (IOP), the active substances of the applied IOP-lowering drugs, the best corrected visual acuity (BCVA) and the mean deviation (MD) of the perimetry were measured at baseline and at regular follow-ups, scheduled at 2 days and 1, 3, 6 and 12 months after surgery. Results153 eyes were included in this analysis. 113 eyes were affected by POAG (74%), 5 eyes by NTG (3%), 22 eyes by PEX (14%) and 13 eyes by Sec.Gl (9%). Mean IOP decreased in all treatment groups during the 12 months of follow-up (complete group: 23.9±7.4 to 15.4±5.1 mmHg (p<0.01); POAG: 22.8±6.5 to 15.1±4.6 mmHg (p<0.01); NTG: 16.6±3.4 to 11.6±2.2 mmHg (p<0.05); PEX: 28.0±7.9 to 17.1±6.6 mmHg (p<0.01); Sec.Gl: 28.9±13.9 to 15.5±6.9 mmHg (p<0.05)). In the 153 eyes the average number of IOP-lowering drugs applied decreased from 2.6±1.2 to 0.8±1.3 12 months after surgery (p<0.01). BCVA and mean deviation of automated standard perimetry remained stable in all groups during follow-up. ConclusionAs in eyes suffering from POAG, IOP and number of IOP-lowering drugs applied can be effectively reduced by XEN implantation in eyes suffering from NTG, PEX and secondary glaucoma while leaving BCVA and visual field unchanged. Trial registrationTrial was registered at DRKS (registration number: DRKS00020800, Registered 25.February 2020 - Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020800)

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Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Cited by 173 publications

References 48 publications

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation

Technique of Xen Implant Revision Surgery and the Surgical Outcomes: A Retrospective Interventional Case Series

Comparison of the effectiveness of the XEN microstent in the treatment of different types of glaucoma

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