Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry.

OBJECTIVES: To evaluate the 1-year effectiveness and safety of the XEN45, either alone or in combination with phacoemulsification, in glaucoma patients. METHODS: This multicentre, prospective, observational study included consecutive eyes of glaucoma patients from the Italian XEN-Glaucoma Treatment Registry (XEN-GTR) who underwent XEN45 alone or in combination with phacoemulsification, with at least 1 year of follow-up. Surgical success was defined as intraocular pressure (IOP) < 18 mmHg and ≥20% reduction from preoperative IOP, over 1 year of follow-up. RESULTS: Two hundred thirty-nine eyes (239 patients) were analyzed, 144 (60.2%) eyes in the XEN-solo and 95 (39.8%) eyes in the XEN+Phaco groups. One hundred-sixty-eight (70.3%) eyes achieved overall success, without statistically significant differences between study groups (p = 0.07). Preoperative IOP dropped from a median (IQR) of 23.0 (20.0-26.0) mmHg to 14.0 (12.0-16.0) mmHg at month 12 (p < 0.001), with overall 39.9 ± 18.3% IOP reduction. The mean number of preoperative ocular hypotensive medications (OHM) was significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (p < 0.001). Preoperative IOP < 15 mmHg (HR: 6.63; 95%CI: 2.61-16.84, p < 0.001) and temporal position of the surgeon (HR: 4.25; 95%CI: 2.62-6.88, p < 0.001) were significantly associated with surgery failure. One hundred-forty-six (61.1%) eyes had no intraoperative complications, whereas 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively early (< month 1) and late (≥ month 1), all self-limiting or successfully treated without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up. CONCLUSION: Over 1-year follow-up, XEN45 alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for OHM.

Safety and Efficacy of Ab Interno XEN 45 Gel Stent in Patients with Glaucoma and High Myopia.

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.

Intraocular pressure control after combined phacotrabeculectomy versus trabeculectomy alone.

PURPOSE: We compared the efficacy and safety of trabeculectomy and phacotrabeculectomy in patients with glaucoma. MATERIALS AND METHODS: We retrospectively analyzed consecutive patients who underwent trabeculectomy or phacotrabeculectomy. Patients in the trabeculectomy group were pseudophakic. We established three different intraocular pressure (IOP) thresholds (A: <21 mmHg, B: <18 mmHg, and C: <15 mmHg) to measure complete (without medication) and qualified (with medication) success. Success criteria were analyzed through Kaplan-Meier survival curves. RESULTS: Sixty-seven eyes were included (40 trabeculectomy, 27 phacotrabeculectomy). The mean follow-up period was 25.70 ± 14.439 months. The baseline characteristics were similar between the groups. The complete and qualified success rates according to criterion C were significantly higher in the trabeculectomy group (p = 0.033, p = 0.021, respectively); however, there was a trend toward a higher success rate for all criteria in favor of trabeculectomy. Bleb needling was more frequent in the phacotrabeculectomy group. The mean IOP significantly decreased from 26.46 ± 7.07 to 12.27 ± 4.06 at 12 months (p < 0.001). The final mean IOP was significantly lower in the trabeculectomy than in the phacotrabeculectomy group (10.95 ± 3.08 vs 13.00 ± 4.56, p = 0.0003). CONCLUSION: In pseudophakic eyes, trabeculectomy alone achieves a higher success rate, lower mean IOP, and less frequent bleb needlings. More frequent follow-up and prolonged postoperative use of high-dose topical steroids should be considered in patients undergoing phacotrabeculectomy.

Prevalence of SARS-CoV-2 amongst ophthalmologists throughout the first and second waves of the pandemic.

ABSTRACT: The study aims to investigate the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among ophthalmology unit staff throughout the first and second waves of the outbreak, in order to verify the effectiveness of the measures adopted in containing the contagion.A retrospective observational study was conducted involving staff members, who received a naso/oropharyngeal swab when complaining of SARS-CoV-2 symptoms and once a month as a screening measure. They were tested for SARS-CoV-2 antibodies as a screening measure during the first and the second wave. Clinical activities performed during the outbreak were compared with those performed during the same period in 2019 and correlated with the number of coronavirus disease-2019 eye care workers.Analysis included 25 workers. Clinical infection was 0% and 12% whereas the prevalence of SARS-CoV-2 antibodies ranged from 4% to 8% in the first and second wave, respectively. The increase in the prevalence of SARS-CoV-2 infection between the first and the second wave was not significant (1/25 vs 3/25, P = .6092). Clinical activities significantly decreased during the first wave compared with the same period in 2019 (3256 vs 10,075, P < .0001, -68% to 2019), but increased during the second wave (8208 vs 3256, P < .0001, +152% to the first wave).Despite the increase in routine activities during the second wave, we did not observe a significant increase in SARS-CoV-2 prevalence. Strict protection measures seemed to contain the rate of contagion among the ophthalmology unit members even in a high-volume clinical setting in one of the most affected area by the coronavirus disease-2019 outbreak.

Medical management of pediatric glaucoma: lessons learned from randomized clinical trials.

PURPOSE: To critically discuss the randomized clinical trials (RCTs) on glaucoma medical therapy for the management of pediatric glaucoma. METHODS: RCTs on glaucoma drugs carried out on pediatric subjects with ocular hypertension and glaucoma were identified through systematic searches. The methods of the RCTs and the safety and the efficacy of the glaucoma drugs were reviewed and discussed. RESULTS: We included five RCTs. One study compared dorzolamide with 0.5% timolol gel; one brinzolamide with 0.5% levobetaxolol; one 0.25% betaxolol, 0.25% timolol gel, and 0.5% timolol gel; one latanoprost with 0.5% timolol; and one travoprost with 0.5% timolol. The primary outcome was safety for two studies and efficacy for three studies. None of the RCTs was powered to detect statistically significant differences in intraocular pressure (IOP) between treatments. In total, 658 subjects received at least one dose of study medication. Beta-blockers were administered to 359 patients, carbonic anhydrase inhibitor (CAI) to 154, and prostaglandins to 145 patients. IOP-lowering efficacy ranged from 20 to 23% for CAI, from 9 to 36% for beta-blockers, and from 26 to 27% for prostaglandins. The percentage of responders was 50% for CAI, ranged from 38 to 74% for beta-blockers and from 60 to 83% for prostaglandins. Two patients receiving timolol experienced a systemic, drug-related serious adverse event (one patient bradycardia and one pneumonia). Systemic, nonserious drug-related events occurred in 15 patients randomized to beta-blockers and in 8 patients randomized to CAI. No adverse events occurred in children treated with prostaglandins. CONCLUSION: RCTs that are available on medical therapy for glaucoma are few and underpowered. The proportion of responders is lower in children; however, in subjects who are responders, the efficacy of glaucoma drugs seemed to be comparable to that in adults. As systemic adverse events have been reported, including serious events with timolol, a particular attempt to minimize the absorption of the drug (using the lowest dose and the gel formulation of beta-blockers or considering the lacrimal punctum occlusion) and a follow-up that is more frequent and more focused on safety should be considered in pediatric subjects who are on topical glaucoma medications.