Four‐year results of a minimally invasive transscleral glaucoma gel stent implantation in a prospective multi‐centre study

Lenzhofer, Markus; Kersten-Gomez, Inga; Sheybani, Arsham; Gulamhusein, Husayn; Strohmaier, Clemens; Hohensinn, Melchior; Dick, H. Burkhard; Hitzl, Wolfgang; Eisenkopf, Lisa; Sedarous, Fady; Ahmed, Iqbal Ike K.; Reitsamer, Herbert A.

doi:10.1111/ceo.13463

Cited by 92 publications

(122 citation statements)

References 24 publications

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“…Regarding how perimetry's mean deviation (MD) has changed as a result of surgery, our study, which included between 80 and 94% of combined surgeries (depending on the patient group), reveals slight changes that are neither intragroup nor intergroup significant, which is in good agreement with Lenzhofer's [18] findings for XEN ® 63 and with Fernández-García [12] for XEN ® 45.…”

Section: Discussionsupporting

confidence: 81%

“…Sheybani et al, [10] in his pilot study in patients undergoing XEN ® 140 or XEN ® 63 implantation combined with cataract surgery (with no use of mitomycin), also reported a mean decrease in IOP of around 30% at 12 months. Similarly, Lenzhofer et al [18], after a 4year follow-up of XEN ® 63-implanted patients, also showed a postoperative drop in IOP of about 40%. In this context, our study seems to be the only one that compares XEN ® 45 and XEN ® 63 outcomes with a follow-up period as lengthy as 36-months, using MMC in all cases.…”

Section: Discussionmentioning

confidence: 63%

“…Other complications that have been reported in the context of XEN ® 45 implantation procedures were device fracture during needling [20], endophthalmitis [21], or degradation of the device [22], but we are happy to report that none of them occurred in our case series, nor was there any procedural failure (defined as presence of a secondary IOP lowering procedure or loss of light perception) [18] during the three-year follow-up period that made it necessary to replace the gel stent. Comparing our outcomes with other studies found in the literature, De Gregorio [16] (XEN ® 63 implantation procedures) reported an 11.8% failure rate, whereas Lenzhofer had 10% of failed XEN ® 63 implantation surgeries [18].…”

Section: Discussionmentioning

confidence: 67%

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Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Fernández-García¹,

Zhou²,

García-Alonso

et al. 2020

Journal of Ophthalmology

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Purpose. To evaluate medium-term clinical outcomes with XEN® 45 or XEN® 63 Gel Stent (Allergan, Dublin, Ireland) for treatment of primary open angle glaucoma (POAG). Materials and Methods. Retrospective, descriptive, and observational study involving 40 patients implanted with a XEN® 45 Gel Stent and 34 implanted with a XEN® 63 Gel Stent who had undergone POAG surgery and had been followed up and controlled between 12 and 36 months. Results. IOP dropped from 18.02 ± 5.23 mmHg preop to 13.81 ± 1.88, 14.80 ± 2.23, and 14.62 ± 1.90 at 1, 2, and 3 years after surgery (p<0.001) consecutively with XEN® 45 and from 19.00 ± 6.11 mmHg preop to 15.47 ± 2.45, 14.66 ± 2.45, and 15.46 ± 2.48 at 1, 2, and 3 years after surgery (p<0.001) with XEN® 63. The number of drugs used by patients to treat their glaucoma decreased after undergoing surgery in both groups. Within the XEN® 45 group, mean changes at 1 year, 2 years, and 3 years amounted to 70%, 74.3%, and 37.5%, respectively, whereas within the XEN® 63 group, the mean reduction was 75%, 79.8%, and 71.9%. When comparing the outcomes for two groups, the differences did not prove to be statistically significant. More than 90% of the procedures included in the study (using either gel-stent device) were completed without any noteworthy complications. Conclusion. POAG surgical procedures with either XEN® 45 or XEN® 63 Gel Stent implantation could be a safe and effective treatment approach.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 67%

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Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Fernández-García¹,

Zhou²,

García-Alonso

et al. 2020

Journal of Ophthalmology

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“…Considering these findings, about a third of all observed patients underwent the procedure during b Fig. 2 Scatterplots of delta IOP as a function of delta PERG AN95 in all patients (n = 20 [21]. Just like in our study, the results were affected by the surgeon's learning curve.…”

Section: Complicationssupporting

confidence: 63%

XEN Gel Stent in the management of primary open-angle glaucoma

et al. 2020

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Purpose To assess the efficacy and safety of the XEN Gel Stent in patients with primary open-angle glaucoma.Materials and methods Twenty eyes of 17 patients (6 males, 11 females) with primary open-angle glaucoma were implanted with XEN Gel Stent. The following data were ascertained in each participant at baseline and at 1, 3, 6, 9 and 12 months following implanting procedure: intraocular pressure, number of anti-glaucoma medications, retinal sensitivity (PS 24/2 w/w), pattern electroretinogram (ISCEV standard), as well as the number of complications. Results The mean intraocular pressure reduction in a 1-year follow-up was 18% (21.56 vs. 17.69 mmHg, p \ 0.001). The mean number of anti-glaucoma medications was reduced from 3.2 to 1.6 (p = 0.001). The PERG parameters at baseline and at 12 months postoperatively included a stable amplitude of P50 (2.55 lV vs. 2.65 lV, p = 0.024) and N95 (3.45 lV vs. 3.38 lV, p = ns) waves. The delta N95 and delta P50 amplitudes remained stable over the follow-up period (p = ns). The mean deviation (MD) of PS 24/2 was -6.54 dB vs. -8.43 dB, p = ns, whereas the pattern standard deviation (PSD) was 6.18 dB vs. 6.91 dB, p = ns. Transient hypotony within the first postoperative week occurred in 18 eyes (90%), whereas hyphema occurred in two eyes (10%). Needle revision of a filtration bleb was performed in five eyes (25%). Conclusions The XEN Gel Stent enables significant reduction in intraocular pressure with very low complication rates. It ensures a stabilization of the retinal function as established with the PERG.

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“…Lenzhofer et al already demonstrated the long-term effectiveness of the XEN microstent in a group of 64 eyes of 64 POAG patients. It was shown that low mean IOP values and reduced necessity for application of IOP-lowering medication can even be found as long as four years after implantation of the XEN microstent [25]. However, these data were collected in eyes in which the XEN 63 was implanted (with a larger internal lumen of 63 µm).…”

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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Four‐year results of a minimally invasive transscleral glaucoma gel stent implantation in a prospective multi‐centre study

Cited by 92 publications

References 24 publications

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation

XEN Gel Stent in the management of primary open-angle glaucoma

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

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