Search Results (8)

Background: To compare the efficacy and safety of the XEN^® 63 µm and 45 µm devices with the ab externo open conjunctiva with a 30G needle approach. Methods: A retrospective, non-randomized and single-center study was conducted. Consecutive eyes undergoing a XEN^® 63 µm implant were compared with a matched cohort of cases with a XEN^® 45 µm implant. Standalone and combined procedures with phacoemulsification were included. Results: A total of 28 XEN^® 45 µm and 28 XEN^® 63 µm were included. Complete surgical success was achieved in 17 cases (60.7%) in the 45 µm group and in 20 cases (71.4%) in the 63 µm group, with no statistical differences. One year after the surgery, the mean IOP was 13.8 ± 3.3 mmHg for the 45 µm group and 12.4 ± 4.2 mmHg for the 63 µm group (p-value > 0.05). Likewise, the use of glaucoma medication was lowered in the 63 µm device (0.32 ± 0.87) compared to the 45 µm device (0.39 ± 0.86), with no statistical significance. Postoperative hypotony was more frequent in the 63 µm device (39.3%) than in the 45 µm group (28.6%), with no statistical differences. However, hypotony-associated complications (including choroidal detachment, hypotony keratopathy, and hypotony maculopathy) were significantly higher in the 63 µm group (p = 0.011). Conclusions: Although the XEN^® 63 µm may offer a greater IOP-lowering effect with better complete surgical success, no significant differences were detected compared to the 45 µm device. Hypotony-related complications were higher in the XEN 63 µm, although most of them resolved with conservative management. Full article

Background: This study aimed to assess the efficacy and safety of the 30G needle mediated ab externo open conjunctiva approach for the XEN 63 µm implant in primary open-angle glaucoma. Methods: A retrospective and non-randomized study was conducted on consecutive cases of medically refractory primary open-angle glaucoma treated with standalone ab externo open conjunctiva XEN^® 63 µm (North Chicago, Illinois) with one-year follow-up. Results: Twenty-two eyes were included. The mean preoperative intraocular pressure was 21.9 ± 7.2 mmHg, and the mean number of glaucoma medications was 2.4 ± 0.9. All patients underwent mitomycin 0.02% application for 2 min, and Healaflow^® (MedicalMix, Spain), was implanted in 11 cases (50%). Complete surgical success was achieved in 14 cases (63.6%). No statistical differences in complete surgical success were noted based on the use of Healaflow^®. A significant reduction in intraocular pressure (11.8 ± 3.4 mmHg) and in the number of hypotensive medications (0.2 ± 0.5 mmHg) was observed 1 year after the procedure. Transient hypotony was detected in 31.8% of cases. Complications secondary to hypotony included four cases of serous choroidal detachment and one case of localized hemorrhagic choroidal detachment, the latter associated with hypotonic keratopathy and hypotonic maculopathy. All these complications evolved favorably with conservative management and adjusted topical treatment. Conclusions: This study highlights the efficacy and safety of this approach for the XEN 63 µm implant in medically refractory primary open-angle glaucoma. Full article

Background: This study aimed to report the efficacy and safety of peribleb autologous blood injections in patients with hypotony maculopathy following trabeculectomy. Methods: In this retrospective chart-review study, patients with hypotony maculopathy from over-filtering bleb following mitomycin C (MMC)-augmented trabeculectomy treated with ≥1 peribleb autologous blood injections, ≥12 months of follow-up, and macula optical coherence tomography (OCT) imaging were included. Patients with previous laser cyclophotocoagulation were excluded. Hypotony maculopathy was defined as choroidal folds in the macular region, as assessed by OCT. Results: Nine patients met the inclusion criteria (mean age 62.3 ± 17.0). The mean intraocular pressure (IOP) at hypotony maculopathy diagnosis was 3.8 ± 1.5 mmHg. Most (n = 7) patients received a single injection (4 injections n = 1, 5 injections n = 1). Significant improvements in mean overall IOP after blood injection were observed (8.3 ± 2.4 mmHg; p = 0.008). Improvements in visual acuity and the resolution of hypotony maculopathy were observed in patients requiring a single injection only. No intra-operative adverse events were recorded. Successful bleb surgical revision was performed for two patients refractory to blood injections. Conclusions: Peribleb autologous blood injection increased IOP, improved visual acuity, and resolved hypotony maculopathy in 5.3 weeks in 7/9 patients. This procedure is not a contra-indication for further surgical revision. Full article

Background: To report the surgical safety of reinforced bio-interventional cyclodialysis with scleral allograft reinforcement. Methods: This was a consecutive case series of 243 eyes with open-angle glaucoma who underwent a bio-scaffolded cyclodialysis (BSC) procedure for uveoscleral outflow enhancement using allogeneic bio-spacers to maintain patency of the internal filtration conduit. Results: 79% of the eyes underwent concomitant phacoemulsification cataract surgery prior to BSC intervention, while the remaining eyes underwent stand-alone BSC surgery. All patients had a postoperative surgical safety period of at least 30 days. There were no sight-threatening or serious ocular adverse events. There was one case of prolonged iritis beyond 30 days, which resolved with topical treatment. Two cases (0.8%) of intraoperative and five (2%) of postoperative non-sight-threatening hyphema were without clinical sequelae, which resolved with conservative management. There were 11 cases of IOP elevation and one case of numeric hypotony without maculopathy, which resolved within the study period. The rate of secondary surgical intervention for IOP control was low, and overall, IOP for the cohort improved in the postoperative period, with 78.6% of eyes achieving IOP ≤ 18 mmHg without an increase in medications. Conclusions: Allogeneic biotissue for cyclodialysis intervention demonstrates a biocompatible ocular profile as an implantable material for internal scleral reinforcement during uveoscleral outflow enhancement surgery. Full article

We aimed to describe a variation of the surgical technique for the ab interno implantation of the XEN Gel Stent, which, in our experience, is yielding very successful results. The injection of 0.1 mL of air and then of 0.1 mL of a dispersive viscoelastic into the subconjunctival space at the beginning of the surgery allows one to perform a mechanical dissection between the conjunctiva and the Tenon’s capsule, creating a real space. In total, 20 eyes of 16 patients underwent the implantation of a stent gel through the “Air and Visco” technique. We retrospectively analyzed the results. We obtained a reduction in the IOP from an average of 18.3 ± 2.2 mmHg preoperatively to at 13.5 ± 3.5 mmHg at month 12. The needling rate was 20%. We did not register any cases of hypotony (IOP < 6 mmHg), hypotony maculopathy or choroidal detachment. The “Air and Visco” technique allows one to correctly place the device in the subconjunctival space, which the pneumo- and visco-dissection transforms into a real space. This enables an easier surgical performance and more predictable postoperative results, with a low needling rate and reintervention in the follow-up period. It also ensures a greater safety profile because the presence of the OVD on the bleb prevents a sudden lowering of the IOP, eliminating complications such as hypotony, hypotony maculopathy and choroidal detachment in our cohort. Full article

This study reports on the safety and efficacy of Xen 45 in patients with glaucoma and high myopia. It was a retrospective study including patients with high myopia (>6D) who underwent Xen implant with 2 years of follow-up. The primary outcome was to report the incidence of hypotony (IOP ≤ 5 mmHg) and hypotony-related complications. Patients with high myopia treated with mitomycin-C-augmented trabeculectomy were included as a control group. We included 14 consecutive patients who underwent Xen implant (seven eyes) and trabeculectomy (seven eyes). The mean myopia was −14.71 ± 5.36 and −15.07 ± 6.11 in the trabeculectomy and Xen groups, respectively (p > 0.05). The success rate and the mean IOP at 1 and 2 years from the intervention were statistically comparable between the two groups. The group undergoing trabeculectomy showed a higher incidence of hypotony (six eyes (85.71%) vs. two eyes (28.57%)) and hypotony maculopathy (three eyes (42.86%) vs. zero eyes (0%)) and required more postoperative procedures. Patients with high myopia were at higher risk of hypotony-related complications after trabeculectomy. The Xen implant can achieve an IOP control comparable to trabeculectomy with a significantly better safety profile and can be considered as an option for the management of patients with high myopia and glaucoma. Full article

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. Full article

PURPOSE: The aim of the study was to assess the efficacy and safety of compressive sutures in patients with hypotony maculopathy after glaucoma surgery. METHODS: This retrospective case series analyzes the clinical outcomes of conjunctival compressive sutures in 17 patients with hypotony maculopathy developed after glaucoma surgery. Compressive Nylon 10–0 single sutures were used in all patients; in two patients, the procedure was repeated. All patients underwent ophthalmic evaluation and macular OCT scanning before the surgery, one month, six months, and one year after the procedure. RESULTS: Mean intraocular pressure (IOP) before suturing was 2.3 ± 1.57 mmHg and increased to 14.2 ± 7.03 mmHg (p = 0.00065) one month after the procedure. After six months, mean IOP was 10.2 ± 4.3 mmHg (p = 0.005), and after one year ± 4.7 mmHg (p = 0.0117). To obtain the target pressure, the sutures had to be removed in one patient, and medical therapy was undertaken in three patients. Mean decimal best-corrected visual acuity (BCVA) before the sutures was 0.18 ± 0.13 and increased to 0.53 ± 0.25 (p = 0.0004) after one month, to 0.46 ± 0.31 (p = 0.005) after six months, and to 0.31 ± 0.22 (p = 0.025) after one year. In one case, leakage from the bleb was observed after the procedure and bleb revision was required. CONCLUSIONS: transconjuctival compressive sutures seem to be an efficient and safe technique for managing hypotony maculopathy after glaucoma surgery. Full article