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.

Efficacy of topical plus intracameral anesthesia for cataract surgery in high myopia: randomized controlled trial.

PURPOSE: To assess the efficacy of intracameral lidocaine supplementation of topical anesthesia during cataract surgery in eyes with high myopia. SETTING: Department of Ophthalmology, Ospedale San Pietro-Fatebenefratelli, Rome, Italy. METHODS: This prospective double-blind study comprised 120 highly myopic eyes with an axial length (AL) greater than 26.0 mm scheduled for routine cataract surgery. Cases were divided into 2 groups of 60 eyes each. One group received a placebo of balanced salt solution (BSS) (control group) and the other group, a supplement of 0.1 mL preservative-free lidocaine hydrochloride 1% injected in the capsular bag during hydrodissection (lidocaine group). Intraoperative pain was assessed by recording spontaneous patient reports of sensation of pain or ocular discomfort during 3 surgical stages: phaco tip insertion, irrigation/aspiration (I/A) system insertion for cortical aspiration, I/A system insertion for ophthalmic viscosurgical device removal after intraocular lens implantation. Postoperative pain was assessed on a visual analog scale (range 0 to 10). Data were compared by chi-square and Mann-Whitney U tests. RESULTS: The overall mean AL was 28.58 mm (28.57 mm control group; 28.50 mm lidocaine group). Fewer patients in the lidocaine group reported intraoperative pain, ocular discomfort, or tissue manipulation (odds ratio=0.36; 95% confidence interval, 0.16-0.80; P= .019). The mean postoperative pain score was 1.88+/-2.17 (SD) in the control group and 1.36+/-2.02 in the lidocaine group; the difference was not statistically significant (P= .21). CONCLUSION: Intracameral lidocaine supplementation for cataract surgery may improve intraoperative comfort under topical anesthesia in highly myopic eyes.