[Clinical results of the eyeWatch system: 1-year outcomes]. / Klinische Ergebnisse des eyeWatch-Systems: 1-Jahres-Outcome.

BACKGROUND: The eyeWatch System (EWS) (Rheon Medical, Lausanne, Switzerland) was developed as a glaucoma drainage device (GDD) to precisely control intraocular pressure (IOP) and thus prevent the development of postoperative hypotension and its complications. OBJECTIVE: To report 1­year outcomes from a single-center cohort undergoing EWS surgery. MATERIAL AND METHODS: Retrospective review of patients undergoing EWS surgery at the University Eye Hospital Bonn, Germany from May 2021 to September 2022. RESULTS: A total of 5 eyes of the first 5 consecutive patients treated with the EWS were included in this study. The mean preoperative IOP was 34.6 mm Hg (23-45 mm Hg) which was reduced to 12.2 mm Hg (9-18 mm Hg) with a mean reduction of 60%. Local pressure-lowering therapy was reduced from 2.8 agents preoperatively (1-4) to 0.6 agents after 1 year. All patients achieved the target IOP of below 21 mm Hg including 4 patients without any medication. The complication rate was low. One patient had to undergo two surgical revisions as the IOP was elevated to over 30 mm Hg after surgery and tube exposure became apparent during the course of the follow-up so that a second donor patch was sutured on. The same patient had an elevated IOP >30 mm Hg after a cMRI examination, so that a reduction of IOP by adjusting the EWS using the eyeWatch pen (EWP) was performed. IOP adjustments with the eyeWatch pen (EWP) were performed in 4 of 5 patients in the first year after surgery; the mean IOP before adjustment was 21.33 mm Hg (15-37 mm Hg) which was reduced to a mean of 8.58 mm Hg (4-16 mm Hg). CONCLUSION: The EWS effectively lowers IOP and the amount of necessary pressure-lowering therapy. With the EWP postoperative adjustments of IOP are possible without further invasive measures.

Clinical outcomes of the PAUL® glaucoma implant: One-year results.

BACKGROUND: To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery. METHODS: Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021. RESULTS: Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%-100%) and 73.3% (60%-86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%-93.3%) and 74.4% (51.1%-80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%-75.6%) and 46.7% (31.2%-62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%-40.0%) and 22.2% (11.1%-33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7-48 mmHg) to 12.0 mmHg (3-24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0-3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2-12 m). Mean IOP before the removal was 21.9 mmHg (12-38 mmHg) and decreased to 11.3 mmHg (6-16 mmHg). CONCLUSIONS: PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.

Five-Year Clinical Outcomes of Inferior Quadrant Trabectome Surgery for Open Angle Glaucoma.

PRCIS: This retrospective study of 264 eyes having inferior quadrant trabectome surgery confirms its safety and relative effectiveness. Most patients however still require IOP-lowering agents, and a considerable proportion may need additional glaucoma surgery. PURPOSE: To report outcomes from a large single-center cohort of inferiorly-applied trabectome surgery. PATIENTS AND METHODS: Retrospective review of patients undergoing trabectome surgery for chronic open angle glaucoma (COAG) at the University Eye Clinic Bonn, Germany, from 2012 to 2020. RESULTS: Two hundred sixty-four eyes of 206 patients with COAG were included. The mean review period was 45.43 (range 12-101) months. One hundred five eyes (39.8%) underwent standalone surgery, of which 74 were pseudophakic and 31 phakic. The mean preoperative IOP was 17.58 mm Hg (range 12-50 mm Hg). One hundred five eyes (39.8%) developed a 'failure event' according to pre-defined criteria at a mean interval of 14.8 months postoperative. In absolute terms, 211 patients (79.9%) had a long-term IOP >14 mm Hg at 7.6 months, 174 patients (65.9%) >16 mm Hg at 10.6 months, 127 patients (48.1%) >18 mm Hg at 10.9 months, and 77 patients (29.2%) >21 mm Hg at 11.1 months. Over a five-year period, overall mean IOP remained stable at 13 mm Hg. The majority of patients were still on glaucoma drops (the mean number reduced from 2.9 to 2.7 agents). Subgroup analyses showed that a higher preoperative IOP was a positive predictor for failure, whereas combined surgery (with phaco) had better IOP outcomes (16.5 mm Hg vs. 19.3 mm Hg, respectively). Forty-one patients (15.5%) developed minor complications: 22 had high postoperative IOP within 3 months, 11 developed a self-resorbing hyphema, and 6 had fibrinous uveitis. CONCLUSIONS: Trabectome surgery is a safe and relatively effective procedure for lowering IOP, but most patients still need IOP-lowering agents, and a considerable proportion may need additional glaucoma surgery within a relatively short time. Inferior quadrant treatment may result in inferior IOP outcomes when compared with nasal quadrant surgery.

Clinical Outcomes of XEN45®-Stent Implantation after Failed Trabeculectomy: A Retrospective Single-Center Study.

BACKGROUND: The implantation of a collagen gel micro-stent (XEN45®) as a minimally invasive form of glaucoma surgery (MIGS) after a failed trabeculectomy (TE) may be an effective option with few risks. This study investigated the clinical outcome of XEN45® implantation after a failed TE, with follow-up data of up to 30 months. MATERIALS AND METHODS: In this paper, we present a retrospective review of patients undergoing XEN45® implantation after a failed TE at the University Eye Hospital Bonn, Germany, from 2012 to 2020. RESULTS: In total, 14 eyes from 14 patients were included. The mean follow-up time was 20.4 months. The mean time duration between the failed TE and XEN45® implantation was 110 months. The mean intraocular pressure (IOP) decreased from 17.93 mmHg to 12.08 mmHg after one year. This value increased again to 17.63 mmHg at 24 months and 16.00 mmHg at 30 months. The number of glaucoma medications decreased from 3.2 to 0.71, 2.0, and 2.71 at 12, 24, and 30 months, respectively. CONCLUSIONS: XEN45® stent implantation after a failed TE did not lead to an effective long-term decrease in IOP and glaucoma medications in many patients in our cohort. Nevertheless, there were cases without the development of a failure event and complications, and others in whom further, more invasive surgery was delayed. XEN45® implantation in some failed trabeculectomy cases may, therefore, be a good option, especially in older patients with multiple comorbidities.

[First clinical results with the PAUL® Glaucoma Implant at the University Eye Hospital Bonn]. / Erste klinische Ergebnisse mit dem PAUL®-Glaukom-Implantat an der Universitäts-Augenklinik Bonn.

BACKGROUND: Glaucoma drainage devices (GDD) are an invasive procedure for the treatment of glaucoma. The PAUL® Glaucoma Implant (PGI) has been developed as a new, innovative therapeutic procedure. The PGI differs from previous GDD with regard to the smaller size of the drainage tube. OBJECTIVE: This study analyses 6­months results of the PGI in terms of effectiveness and safety. METHODS: A database of patients treated with the PGI at the University Eye Hospital Bonn was created and continuously updated based on follow-up controls. Statistical analysis was performed using SPSS Statistics for Windows (IBM Corp., Armonk, NY, USA). RESULTS: A total of 53 eyes of the first 51 consecutive patients treated with the PGI were included in this study. Mean intraocular pressure was 26.62 mmHg (7-48 mmHg) preoperatively and reduced to 12.20 mmHg (3-22 mmHg) after 6 months. Local pressure-lowering therapy was reduced from 3.37 agents preoperatively to 0.30 agents after 6 months. The complication rate was low; only 3 patients (5.8%) had persistent hypotony. In 16 patients, the intraluminal prolene stent was removed in the postoperative course after an average of 2.9 months. Thereafter, these patients experienced a reduction of intraocular pressure from 22.21 to 11.07 mmHg. CONCLUSION: The PAUL® Glaucoma Implant is a safe treatment modality that can successfully reduce intraocular pressure to a low level and reduce pressure-lowering local therapy. It has a low complication rate, particularly regarding postoperative hypotony.