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Purpose To establish the safety and efficacy of an ab-interno gelatin stent, as a stand-alone procedure, in combination with a preoperative mitomycin C injection in reducing IOP and anti-glaucoma medications in patients presenting with primary open angle glaucoma. Mean IOP, IOP change, reduction in medications, and safety were recorded in 70 subjects through 12 months. Methods In this prospective, non-randomized, multi-center evaluation, safety and efficacy parameters were evaluated. As a stand-alone glaucoma procedure, a trans-scleral gelatin stent is placed through a clear corneal incision using a preloaded injector with a 27 gauge needle. Once in place, the permanent gelatin implant is designed to connect the anterior chamber to the non-dissected Tenon's and subconjunctival space, thereby creating diffuse dispersion of aqueous while bypassing potential outflow obstructions. Effectiveness was assessed by comparing medicated baseline IOP and glaucomatous medications to postoperative values through 12 months. Safety was assessed by assessing complications at routinely scheduled exams through 12 months. Results No major adverse events were reported, and 2 patients were converted to a tube shunt at 6 months. The mean preoperative (best medicated) IOP was 23.6 mmHg. The mean postoperative IOPs were: 13.3 mmHg (44% reduction) at 9 months, and 12.6 mmHg (47% reduction) at 12 months. From the preoperative mean of 3.5 (patients not washed out pre-surgery), 9 months medications were reduced by 69% and at 12 months medications were reduced by 66%. No infection, migration or erosion occurred in any patients. Conclusions This 'hybrid system', combining a minimally invasive ab-interno approach with a subconjunctival drainage, provided very satisfactory intra-ocular pressure control after one year with an excellent safety profile. [ABSTRACT FROM AUTHOR]

Purpose: To assess the 3-year effectiveness and safety of the XEN gel stent implanted ab interno in open-angle glaucoma (OAG)., Methods: This study was a multicentre, retrospective chart review of consecutive patients with OAG who underwent ab-interno gel stent placement alone or combined with phacoemulsification between 1 January 2014 and 1 October 2015. Outcome measures included mean changes in intraocular pressure (IOP) and IOP-lowering medication count from medicated baseline at 1, 2, 3 (primary outcome) and 4 years (if available) postimplantation. Intraoperative complications, adverse events of special interest (AESIs) and secondary surgical interventions (SSIs) were recorded., Results: The safety and effectiveness populations included 212 eyes (primary and secondary) and 174 eyes (primary), respectively. Mean IOP and medication decreased from 20.7 mmHg and 2.5 at baseline (n = 163 primary/first implanted eyes) to 13.9 mmHg and 1.1 medications (n = 76) at 3 years postimplantation, respectively. Mean changes from baseline in IOP (-5.6, -6.2 and -6.6 mmHg) and IOP-lowering medication count (-1.8, -1.6 and -1.4) were statistically significant at 1, 2 and 3 years postimplantation, respectively. Results appeared comparable when implantation was performed with (n = 76) or without (n = 98) phacoemulsification. In primary eyes with 4-year IOP and medication count data (n = 27), mean IOP was 14.0 mmHg on 1.3 medications at 4 years postimplantation. Fifteen (7.1%) eyes had intraoperative complications, 31 (14.6%) experienced 46 postoperative AESIs, and 26 (12.3%) required SSI., Conclusion: The gel stent effectively lowered IOP and IOP-lowering medication count over 3 years, with a predictable and acceptable safety profile, when implanted via the traditional ab-interno technique., (© 2021 AbbVie Inc. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Objectives/hypothesis: Traumatic optic neuropathy (TON) is an important cause of severe visual impairment following blunt or penetrating head trauma. Treatment options include steroids, decompression, or both. Studies have failed to show a clear benefit for either steroids or surgery or a combined therapy. This study describes the visual outcome in surgically managed patients with or without steroid treatment., Study Design: Retrospective analysis., Methods: In a retrospective chart review we included patients (n = 42) with TON who were managed with optic nerve decompression surgery with or without steroids. Comparison of initial and final visual acuity was the primary outcome parameter., Results: In 42 consecutive patients, steroids were used in 21 cases (50%). Ten patients received a high-dose systemic regimen of more than 500 mg methylprednisolone initial dose, and 11 patients were treated with a lower dose. The overall visual improvement rate was 33%, no change was noted in 50%, and no outcome data were available in 17%. The visual improvement rate of patients treated with decompression surgery and steroids was lower (29%, 6 of 21) than those treated with surgery alone (53%, 8 of 15). Comparing both groups, additional steroids had no beneficial effect on the visual outcome (P = .97). There was no case with a deterioration of visual function due to therapy., Conclusions: In patients with traumatic optic neuropathy who were treated with optic nerve decompression surgery, steroids had no beneficial effect on the visual outcome., Level of Evidence: 2c., (Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.)