ABSTRACT
PURPOSE: To evaluate the efficacy and safety of the XEN63 Gel Stent in patients with open-angle glaucoma (OAG). METHODS: Prospective, nonrandomized, open-label, not-controlled, and single center study conducted on OAG patients who underwent glaucoma surgery with the XEN63 gel stent. The main outcome measure was intraocular pressure (IOP). Secondary end-points were number of topical ocular hypotensive drugs, percentage of patients achieving an IOP reduction ⩾20%, and treatment-related adverse events. RESULTS: Eleven eyes from 11 patients were treated with XEN 63. Mean (95% confidence interval, CI) age was 78.8 (73.7-85.9). Two eyes (18.2%) underwent XEN alone, while nine eyes (81.8%) underwent combined XEN + cataract extraction (phacoemulsification). The median (95% CI) IOP reduction was 17.7% (-13.3% to 34.9%). At the end of the study 9 (81.8%) eyes had an IOP ⩽ 18 mm Hg, six of them without treatment. Six (54.6%) eyes obtained an IOP reduction ⩾20%. Compared to baseline, there was a significant reduction in the number of ocular hypotensive drugs (p = 0.0039). There were no treatment-related serious adverse events. Early postoperative complications included diplopia (1), blood in endothelium (2), ocular hypertension (1), corneal edema (1), folds in Descemet's membrane (1), and contact between the implant and the iris (1). All the adverse events were successfully solved without sequalae. One eye required bleb needling. CONCLUSION: The XEN63 implant significantly reduced both IOP and the amount of ocular hypotensive medications while maintaining a good safety profile.
Subject(s)
Glaucoma Drainage Implants , Glaucoma, Open-Angle , Glaucoma , Follow-Up Studies , Glaucoma, Open-Angle/surgery , Humans , Intraocular Pressure , Prospective Studies , Stents , Treatment OutcomeABSTRACT
PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. PURPOSE: The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. METHODS: Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported. RESULTS: The mean change in intraocular pressure from baseline to day 84 was -0.49±1.80 mm Hg for preservative-free T2347 and -0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84. CONCLUSIONS: Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.
Subject(s)
Benzalkonium Compounds/administration & dosage , Glaucoma, Open-Angle/drug therapy , Latanoprost/administration & dosage , Ocular Hypertension/drug therapy , Preservatives, Pharmaceutical/administration & dosage , Timolol/administration & dosage , Adult , Aged , Aged, 80 and over , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/adverse effects , Benzalkonium Compounds/adverse effects , Drug Combinations , Equivalence Trials as Topic , Female , Glaucoma/drug therapy , Glaucoma, Open-Angle/physiopathology , Humans , Intraocular Pressure/drug effects , Latanoprost/adverse effects , Male , Middle Aged , Ocular Hypertension/physiopathology , Ophthalmic Solutions/administration & dosage , Preservatives, Pharmaceutical/adverse effects , Timolol/adverse effects , Tonometry, Ocular , Treatment OutcomeABSTRACT
PURPOSE: To report an unusual complication of accommodative intraocular lens (IOL) implantation after clear lens extraction for hyperopia correction. DESIGN: Observational case report. METHOD: A 48-year-old woman underwent clear lens exchange for the correction of moderate hyperopia. A Crystalens Model AT-45 Accommodating Posterior Chamber IOL (AT-45 IOL) was implanted to allow optimal distance and near vision. At the 3-week follow-up appointment, she complained of monocular diplopia. Ocular examination showed an increased astigmatism, causing decreased visual acuity. Scheimpflug Pentacam Image and Wave Front Analysis supported the diagnosis of IOL tilting. RESULTS: IOL repositioning was unsuccessful because of fibrosis of the haptics. It was necessary to replace AT 45 IOL with a monofocal acrylic sulcus-fixated IOL. CONCLUSION: Control of capsular fibrosis should be a major concern, especially in this type of IOL. Accommodating IOL exchange appears to be a safe alternative to manage this complication.
