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.

Sterile Corneal Infiltrates following Cataract Surgery: Case Series.

We report a case series of 26 eyes of 26 patients undergoing planned cataract surgery from December 2021 to March 2022, who were diagnosed as having whitish round infiltrates in the surgical corneal incisions. The infiltrates were detected at the first check after 5-8 days from cataract surgery and were located either within the main corneal incision and/or in the smaller incisions. Corneal infiltrates (CIs) were single or multiple, without epithelial defects, and painless. All infiltrates were initially treated with full topical antibiotic coverage, in order to control eventual and serious postsurgical infection. However, at daily checks, the clinical course of CIs suggested a sterile etiology. For this reason, steroidal topical treatment was maintained for a long time with slow tapering until complete remission of the CIs. All infiltrates resolved completely in around 30-40 days. The surgical instruments and the sterilization process were scrutinized. A white amorphous material was found mainly on non-disposable anterior chamber cannulas and on irrigation/aspiration tips. Disposable cannulas were adopted, and machinery for cleaning and sterilization procedures were reviewed, with specific reference to water softener renewal. Thanks to these precautions, CIs never occurred again. Finally, our hypothesis was an immune corneal reaction to amorphous deposit on cannula tips. This case series describes a previously unknown complication of cataract surgery and our experience might be useful for other surgeons.

Italian Candidates for the XEN Implant: An Overview from the Glaucoma Treatment Registry (XEN-GTR).

Background The Italian XEN Glaucoma Treatment Registry (XEN-GTR) was created to acquire a comprehensive prospective dataset that includes the patient characteristics, intraoperative variables, and postoperative management of glaucoma patients undergoing the XEN gel stent implantation. Methods This was a prospective observational, longitudinal clinical study involving 10 centres throughout Italy. The baseline examination included a comprehensive evaluation of demographic parameters (age, sex, ethnicity, and systemic condition), specific ophthalmological parameters, and quality of life questionnaire score collection. Results The baseline data of 273 patients were analysed. The median (IQR) age was 72 (65.0 to 78.0) years. Of the 273 patients, 123 (45%) were female and 150 (55%) were male. A total of 86% of the patients had open-angle glaucoma with a mean intraocular pressure of 24 ± 6 (range 12.0-60.0) mmHg. The mean number of medications was 2.7 ± 0.9 at baseline for the patients with a prevalence of prostaglandin analogues combined with a beta-blocker and anhydrase carbonic inhibitor (31.8%). The mean scores of the NEI-VFQ 25 and GSS questionnaires were 78 ± 18 (range 26.5-100) and 85 ± 14 (range 79-93), respectively. Combined XEN/cataract surgeries were scheduled in 73.7% of the patients. The preferred place for the XEN implant was the supero-nasal quadrant (91.6%). Conclusions Observing the baseline characteristics of the typical Italian candidates for the XEN gel implant shows that they are patients affected by POAG and cataracts, with moderate to severe glaucoma damage, all of which has an impact on their quality of life.

Human vitreous concentrations of citicoline following topical application of citicoline 2% ophthalmic solution.

PURPOSE: To evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in human eyes after topical application of an ophthalmic solution of citicoline 2%, in vivo. METHODS: Twenty-one subjects affected by epiretinal membrane with surgical indication for pars-plana vitrectomy underwent treatment with 1 drop 3 times/day of a solution of citicoline 2%, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride (OMK1, Omikron Italia s.r.l., Rome, Italy) 14 days before surgery and 2 hours prior to surgery. Five additional patients served as controls and received an OMK1 vehicle solution without citicoline. The vitreous samples were taken at the beginning of the pars-plana vitrectomy and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography. RESULTS: The overall mean concentration of citicoline in patients treated with citicoline 2% solution was 406.72 ± 52.99 µg/mL, while the mean concentration of choline, cytidine and uridine was 180.88 ± 41.49 µg/mL, 44.45 ± 10.19 µg/mL and 330.41 ± 75.8 µg/mL, respectively. The concentration of citicoline in phakic eyes (n = 13, 366.61 ± 129.61 µg/mL) was lower compared to that found in pseudophakic eyes (n = 8, 435.89 ± 131.42 µg/mL) and the difference was not statistically significant. The concentration of citicoline in the control eyes was 45.66 ± 26.36 µg/mL, while the concentration of choline, cytidine and uridine were 17.21 ± 9.93 µg/mL, 6.24 ± 3.6 µg/mL and 172.80 ± 99.76 µg/mL, respectively. CONCLUSION: Citicoline can reach the human vitreous in high concentration when administered in ophthalmic solution. This evidence contributes to the build-up of the pyramid of the evidences required for determining the role of citicoline administered in ophthalmic formulation in retinal and optic nerve neurodegenerative diseases.

Brinzolamide 1%/timolol versus dorzolamide 2%/timolol in the treatment of open-angle glaucoma or ocular hypertension: prospective randomized patient-preference study.

PURPOSE: The objective of this study was to assess preference for fixed-combination brinzolamide 1%/timolol 0.5% (BTFC) versus fixed-combination dorzolamide 2%/timolol 0.5% (DTFC) in patients with open-angle glaucoma or ocular hypertension. METHODS: In this prospective, single-masked crossover study, patients were randomized 1:1 to BTFC-DTFC or DTFC-BTFC treatment sequences. Patients self-administered each medication for 7 days, with a 48-hour washout period between treatments, and rated ocular discomfort after each treatment period. Medication preferences based on ocular comfort (primary endpoint) and anticipated adherence were assessed. Safety outcomes included adverse events and intraocular pressure. Between-group differences in treatment preference and ocular discomfort scores were analyzed using chi-square and Wilcoxon-Mann-Whitney tests, respectively. Adherence, intraocular pressure, and adverse events were summarized descriptively. RESULTS: In total, 112 patients were enrolled (mean ± SD age, 66±11 years), and 109 patients completed the study. Numerically, more patients in the intent-to-treat dataset preferred BTFC versus DTFC (59.3% versus 40.7%); however, this result was not statistically significant (treatment difference, 18.6%; P=0.0670). Mean ocular discomfort scores (range, 0-9) were statistically significantly lower with BTFC versus DTFC (2.6 versus 3.7; P=0.0002, Wilcoxon- Mann-Whitney test). More patients who preferred BTFC over DTFC were confident that they would adhere to their preferred medication. Treatment-related adverse events included blurred vision with BTFC and eye irritation or eye pain with DTFC. CONCLUSION: BTFC and DTFC were preferred by approximately 60% and 40% of patients, respectively, and BTFC was associated with less patient-reported ocular discomfort. Greater ocular comfort of glaucoma medications may improve treatment adherence.