RESUMO
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.
Assuntos
Implantes para Drenagem de Glaucoma , Glaucoma de Ângulo Aberto , Glaucoma , Humanos , Estudos Prospectivos , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/cirurgia , Glaucoma de Ângulo Aberto/complicações , Stents , Pressão Intraocular , Glaucoma/tratamento farmacológico , Glaucoma/cirurgia , Glaucoma/complicações , Resultado do Tratamento , Estudos RetrospectivosRESUMO
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.