Mid-term surgical success after transscleral ab interno glaucoma gel stent implantation.

PURPOSE: To investigate the surgical success and efficacy of XEN45 implantation (XEN45 µm, AbbVie Inc., USA) with and without combined cataract surgery up to the first 5 years. METHODS: In a prospective observational monocentric trial, 192 eyes of 157 patients with open-angle glaucoma received either XEN45 implants only (solo surgery group) or combined surgery/cataract surgeries (combined surgery group). Surgical success (qualified and full success; IOP-limit: ≤12, 15, 18, 21 mmHg), time to secondary IOP-lowering procedure, IOP and number of IOP-lowering medications were analysed for 1, 2, 3, 4 and 5 years. RESULTS: Compared to baseline, IOP (24.1 ± 8.1 to 12.6 ± 2.8 mmHg, -48%, p < 0.001) and the number of IOP-lowering medications (3.0 ± 1.0 to 1.5 ± 1.2, -50%, p < 0.001) decreased significantly at 5 years. Although no differences between IOP and the number of IOP-lowering medication courses between the groups were detected at 5 years (p > 0.11), the combined procedure (63%, 37%) showed better success rates compared to the solo procedure (36%, 13%) in the definition IOP ≤18 and ≤12 mmHg (p = 0.035, 0.028). Solo XEN45 procedures had a higher rate of secondary IOP-lowering procedures compared to combined XEN45 cataract procedures (hazard ratio: 2.02, 95%CI: 1.03-3.97, p = 0.04). Twenty per cent of the eyes, including both procedures, required a secondary IOP-lowering procedure within 5 years. CONCLUSIONS: The XEN45 implant is effective in lowering IOP and the number of IOP-lowering medications in patients with open-angle glaucoma in the mid-term. Comparing XEN45 implant results with the results of trabeculectomy available in current literature, we speculate that there might be a higher surgical success rate without medications in favour of trabeculectomy.

Radius-Maumenee syndrome: A case series with a long-term follow-up.

The aim of the case series is to highlight the surgical challenges experienced like failed intervention, choroidal effusion, a postoperative cystoid macular oedema, and describe treatment options for Radius-Maumenee syndrome. Authors reported on 3 bilateral cases of Radius-Maumenee syndrome which underwent medical treatment, trabeculectomy with Mitomycin C, implantation with XEN45, Ahmed glaucoma valve, Baerveldt glaucoma implant, and cyclophotocoagulation.

Five-year follow-up of corneal endothelial cell density after transscleral ab interno glaucoma gel stent implantation.

PURPOSE: This study investigates the course of the endothelial cell density over a period of 5 years after XEN45 implantation (XEN45µm, Allergan Plc., USA) with or without combined cataract surgery. METHODS: This is a prospective, cross-sectional, monocentric, non-randomized clinical trial with the intention to treat a population of the University Eye Clinic Glaucoma Service Salzburg. One hundred and fifty-five eyes with preoperative central corneal endothelial cell counts were subjected to XEN45 implantation with (combined surgery group) or without (solo surgery group) combined cataract surgery. Endothelial cell density was measured at 3 corneal positions. XEN45 location parameters were determined with anterior segment OCT and gonioscopy. RESULTS: In the combined surgery group, a significant reduction of central endothelial cell count was found at years 2 and 4 when compared to baseline (p = 0.001 and p = 0.02, n = 86), whereas at years 1, 3, and 5, no change was detected (all p > 0.09). The median reduction of endothelial cell count was - 79 (95% CI: - 183 to - 9) and - 93 (95% CI: - 220 to 23) cells at years 2 and 4, respectively. In the solo surgery group (n = 69), no significant change in endothelial cell counts was detected at any time during the 5-year evaluation period (all p > 0.07). Explorative data analyses revealed that XEN45 location parameters did not significantly influence the course of endothelial cell count over time. CONCLUSIONS: Endothelial cell loss after XEN45 implantation seems to be low. The present data suggest no impact on the position of the implant with regard to central endothelial cell counts in this study.

Two-year efficacy after first transscleral controlled cyclophotocoagulation in patients with and without pseudoexfoliation.

PURPOSE: Transscleral controlled cyclophotocoagulation (COCO) is a transscleral 810-nm diode laser cyclophotocoagulation that automatically adjusts the applied laser energy utilizing an optical feedback loop. The present study investigates the influence of pseudoexfoliation (PEX) on the efficacy of COCO in a Caucasian study population. METHODS: Retrospective data from 130 consecutive eyes were analyzed during a 2-year follow-up. Baseline characteristics, intraocular pressure (IOP), number of IOP-lowering medications, visual field, best-corrected visual acuity (BCVA), and secondary surgical interventions (SSI) were analyzed. The primary endpoint was IOP reduction at M24 compared to baseline, and the secondary endpoints were IOP course, reduction of IOP-lowering medications, surgical success, and IOP-lowering SSIs stratified by PEX and baseline IOP. RESULTS: IOP reductions of -35, -39, -25, -25, -23, -34, and -36% could be achieved from baseline to D1, W1, M1, M3, M6, M12, and M24 (all p < 0.001), respectively, while there was a significant overall reduction over time (p < 0.001) in the number of topical IOP-lowering medications postoperatively. The proportion of eyes requiring additional systemic IOP-lowering medication reduced from 31 to 0% at M24 (p = 0.025). Eyes without PEX and IOP < 30 mmHg at baseline had the lowest risk for IOP-lowering SSIs (p < 0.03). BCVA dropped at M12 (0.25 [95% CI: 0.12-0.38]), and the drop persisted during the following 12 months. CONCLUSION: The present study demonstrates a midterm IOP-lowering effect after COCO while reducing the burden for topical and systemic IOP-lowering medications. Patients without PEX and IOP < 30 mmHg have a lower risk of SSI. The procedure per se cannot be excluded as causative for the decreased postoperative BCVA. Further prospective investigations are suggested.

Change in visual acuity 12 and 24 months after transscleral ab interno glaucoma gel stent implantation with adjunctive Mitomycin C.

PURPOSE: To analyze changes in best-corrected visual acuity (BCVA) after implantation of the transscleral ab interno glaucoma gel stent (XEN Gel Stent; Allergan, Dublin) in patients with open-angle glaucoma. METHODS: In a single-center, prospective, non-randomized study of 137 eyes with open-angle glaucoma which underwent implantation with XEN, 69 eyes underwent XEN implantation alone (group 1) and 68 eyes underwent XEN implantation and cataract surgery (group 2). BCVA (Bailey-Lovie chart, logMAR scale) was evaluated at baseline, postoperative day 1, weeks 1 and 2, and months 1, 3, 6, 12, and 24. Risk factors for decline in BCVA were analyzed in multivariate models. RESULTS: Baseline BCVA in group 1 was 0.21 ± 031; the group's mean BCVA did not change at any postoperative visit, although a ≥ 2-line loss of BCVA was detected in 15% (95% CI 7-29%) and 4% (95% CI 0-20%) after months 12 and 24, respectively. Baseline BCVA in group 2 was 0.33 ± 031; vision increased significantly at months 3 (0.22 ± 0.29, p = 0.015), 6 (0.20 ± 0.26, p = 0.006), 12 (0.18 ± 0.29, p = 0.001), and 24 (0.18 ± 0.29, p = 0.005). A ≥ 2-line loss of BCVA was reported in 4% (95% CI 1-15%) and 7% (95% CI 1-24%) after months 12 and 24, respectively. CONCLUSIONS: There was no deterioration of BCVA in group 1; those in group 2 had an overall significant increase in BCVA. BCVA decrease was lower than is typically reported in the literature post-trabeculectomy.

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

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 (-54% versus -19%, p < 0.001), week 2 (-39% versus -21%, p = 0.02), month 1 (-42% versus -28%, p = 0.035) and month 12 (-39% versus -24%, p = 0.024). The mean absolute IOP was lower in intra- and subtenon group at week 1 (10.8 [95%CI, 8.8-14.1] versus 16.6 [95%CI, 14.1-19.0] mmHg, p < 0.001) and months 12 (13.9 [95%CI, 12.4-15.4] versus 16.7 [95%CI, 14.6-18.8] mmHg, p = 0.041). At month 6, a lower burden for IOP-lowering medication was shown for the intra- and subtenon group (0.2 ± 0.5 versus 1.0 ± 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 ± 1.7 versus 1.2 ± 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.

Longitudinal bleb morphology in anterior segment OCT after minimally invasive transscleral ab interno Glaucoma Gel Microstent implantation.

PURPOSE: Like the classic trabeculectomy, the minimally invasive, ab interno XEN Glaucoma Gel Microstent (XEN-GGM) creates a filtration bleb in the conjunctiva. The goal of this study was to investigate internal bleb morphology over time with anterior segment optical coherence tomography (AS-OCT) after XEN-GGM implantation. METHODS: In a prospective, single-centre, single-armed cohort study, blebs were characterized using AS-OCT in 78 eyes of 60 patients at day 1, at weeks 1 and 2 and at months 1, 3, 6, 9 and 12 after XEN-GGM implantation in patients with open-angle glaucoma. Morphological bleb characteristics were correlated with IOP and surgical success. RESULTS: Anterior segment optical coherence tomography data indicate early and late bleb changes in the course of 12 months. Uniform blebs in AS-OCTs showed higher IOPs at all examinations between week 1 (17.7 ± 4.8 mmHg versus 11.3 ± 7.1 mmHg, p = 0.001) and month 3 (16.4 ± 6.1 versus 13.4 ± 6.1, p = 0.04). Subconjunctival tissue separation bleb morphology was associated with lower mean IOPs during the course of 12 months (r = -0.75, p = 0.031). Predictors for surgical failure at month 12 were microcystic multiform bleb morphology in AS-OCT at month 3 (60% versus 15%, relative risk 4.0, p = 0.043) and uniform bleb morphology at month 9 (33% versus 23%, relative risk 1.4, p = 0.015). CONCLUSION: Bleb appearance after XEN surgery seems to be different to classic trabeculectomy literature. The present data suggest correlation of IOP and surgical long-term success with bleb morphology in AS-OCT. Prevalence of small diffuse cysts is directly associated with lower IOPs, while cystic encapsulation at 3 months predicts higher surgical failure.