Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: Two-Year Results from a Randomized, Multicenter Study.

PURPOSE: To compare the effectiveness and safety of the MicroShunt (Santen Inc) versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, multicenter trial conducted in the United States and Europe. PARTICIPANTS: Adult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥ 15 mmHg and ≤ 40 mmHg. METHODS: Patients were randomized 3:1 to stand-alone MicroShunt implantation (n = 395) or trabeculectomy (n = 132), both augmented with mitomycin C (MMC) 0.2 mg/ml for 2 minutes. MAIN OUTCOME MEASURES: The primary effectiveness end point was surgical success, defined as ≥ 20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary end points included changes in mean IOP and medication use from baseline and the need for postoperative interventions. RESULTS: At 2 years, the rate of surgical success was lower in the MicroShunt group than in the trabeculectomy group (50.6% vs. 64.4%, P = 0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (P < 0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the 2 groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% vs. 30.9%, P < 0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups. CONCLUSION: At 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study.

PURPOSE: To compare the effectiveness and safety of the MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG). DESIGN: One-year results from a 2-year, prospective, randomized, multicenter, noninferiority study (NCT01881425) conducted in the United States and Europe. PARTICIPANTS: Eligible patients were aged 40-85 years with intraocular pressure (IOP) ≥15 and ≤40 mmHg and mild-to-severe POAG inadequately controlled on maximum tolerated medical therapy. METHODS: Patients were randomized 3:1 to undergo stand-alone MicroShunt implantation or trabeculectomy, both performed with adjunctive mitomycin C (0.2 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary effectiveness end point was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline (no medication washout) at year 1 without increasing the number of glaucoma medications. Secondary effectiveness end points at year 1 were the mean IOP change from baseline and requirement for postoperative intervention. Additional end points included glaucoma medication use and adverse events. RESULTS: Overall, 395 (MicroShunt) and 132 (trabeculectomy) patients were randomized (mean Humphrey visual field mean deviation, -12.34 decibels [dB]). At year 1, probability of success was lower in the MicroShunt group compared with the trabeculectomy group (53.9% vs. 72.7%, respectively; P < 0.01). In the MicroShunt group, mean IOP ± standard deviation decreased from 21.1 ± 4.9 mmHg at baseline to 14.3 ± 4.3 mmHg (-29.1%; P < 0.01) at year 1, with a mean of 0.6 ± 1.1 glaucoma medications (baseline 3.1 ± 1.0; P < 0.01). In the trabeculectomy group, mean IOP decreased from 21.1 ± 5.0 mmHg to 11.1 ± 4.3 mmHg (-45.4%; P < 0.01), with a mean of 0.3 ± 0.9 glaucoma medications (baseline 3.0 ± 0.9; P < 0.01). Postoperative interventions, including laser suture lysis, were reported in 40.8% (MicroShunt) versus 67.4% (trabeculectomy) of patients (P < 0.01). Reported incidence of transient hypotony was higher in the trabeculectomy group versus the MicroShunt group (49.6% vs. 28.9%; P < 0.01). Vision-threatening complications were uncommon and reported in 1.0% of MicroShunt versus 0.8% of trabeculectomy patients. CONCLUSIONS: Probability of success was lower with MicroShunt compared with trabeculectomy. Although reductions in IOP and glaucoma medications over 1 year were observed in both groups, the trabeculectomy group had a lower mean IOP on fewer medications.

A novel bilayered expanded polytetrafluoroethylene glaucoma implant creates a permeable thin capsule independent of aqueous humor exposure.

The purpose of these studies was to evaluate clinical, functional, and histopathological features of glaucoma drainage implants (GDIs) fabricated from novel, custom-tailored expanded polytetrafluoroethylene (ePTFE). Implants of matching footprints were fabricated from silicone (Control) and novel, bilayered ePTFE. ePTFE implants included: (a) one that inflated with aqueous humor (AH) (High), (b) one that inflated with a lower profile (Low), (c) an uninflated implant not connected to the anterior chamber (Flat), and (d) one filled with material that did not allow AH flow (Filled). All implants were placed in adult New Zealand White rabbits and followed over 1-3 months with clinical exams and intraocular pressure. The permeability of tissue capsules surrounding GDIs was assessed using constant-flow perfusion with fluoresceinated saline at physiologic flow rates. After sacrifice, quantitative histopathological measures of capsule thickness were compared among devices, along with qualitative assessment of cellular infiltration and inflammation. Capsular thickness was significantly reduced in blebs over ePTFE (61.4 ± 53 µm) versus silicone implants (193.6 ± 53 µm, p = .0086). AH exposure did not significantly alter capsular thickness, as there was no significant difference between High and Filled (50.9 ± 29, p = .34) implants. Capsules around ePTFE implants demonstrated permeability with steady-state pressure: flow relationships at physiologic flow rates and rapid pressure decay with flow cessation, while pressure in control blebs increased even at low flow rates and showed little decay. Perfused fluorescein dye appeared beyond the plate border only in ePTFE implants. ePTFE implants are associated with thinner, more permeable capsules compared to silicone implants simulating presently used devices.

Cost-comparison of two trabecular micro-bypass stents versus selective laser trabeculoplasty or medications only for intraocular pressure control for patients with open-angle glaucoma.

AIM: Patients with open-angle glaucoma (OAG) whose intraocular pressure is not adequately controlled by one medication have several treatment options in the US. This analysis evaluated direct costs of unilateral eye treatment with two trabecular micro-bypass stents (two iStents) compared to selective laser trabeculoplasty (SLT) or medications only. MATERIALS AND METHODS: A population-based, annual state-transition, probabilistic, cost-of-care model was used to assess OAG-related costs over 5 years. Patients were modeled to initiate treatment in year zero with two iStents, SLT, or medications only. In years 1-5, patients could remain on initial treatment or move to another treatment option(s), or filtration surgery. Treatment strategy change probabilities were identified by a clinician panel. Direct costs were included for drugs, procedures, and complications. RESULTS: The projected average cumulative cost at 5 years was lower in the two-stent treatment arm ($4,420) compared to the SLT arm ($4,730) or medications-only arm ($6,217). Initial year-zero costs were higher with two iStents ($2,810) than with SLT ($842) or medications only ($996). Average marginal annual costs in years 1-5 were $322 for two iStents, $777 for SLT, and $1,044 for medications only. The cumulative cost differences between two iStents vs SLT or medications only decreased over time, with breakeven by 5 or 3 years post-initiation, respectively. By year 5, cumulative savings with two iStents over SLT or medications only was $309 or $1,797, respectively. LIMITATIONS: This analysis relies on clinical expert panel opinion and would benefit from real-world evidence on use of multiple procedures and treatment switching after two-stent treatment, SLT, or polypharmaceutical initial approaches. CONCLUSIONS: Despite higher costs in year zero, annual costs thereafter were lowest in the two-stent treatment arm. Two-stent treatment may reduce OAG-related health resource use, leading to direct savings, especially over medications only or at longer time horizons.

LONG-TERM RESULTS OF COMBINED AB INTERNO TRABECULOTOMY (TRABECTOME) AND SMALL-GAUGE PARS PLANA VITRECTOMY.

PURPOSE: To report outcomes of patients who have undergone combined Trabectome and pars plana vitrectomy. METHODS: Institutional Review Board-approved retrospective chart review of patients seen at the Cincinnati Eye Institute before January 2014 undergoing combined Trabectome and pars plana vitrectomy for uncontrolled glaucoma and visually significant retina pathology. Charts were reviewed to identify changes in intraocular pressure, visual acuity, and change in glaucoma medication requirement up to 1 year after surgery. RESULTS: Four patients met the inclusion criteria with 12-month follow-up, and two of the patients were male. All patients underwent 25-gauge pars plana vitrectomy and Trabectome surgery. Mean preoperative LogMAR visual acuity was 0.39 (20/49) and 12-month LogMAR visual acuity was 0.21 (20/32) (P = 0.06). Mean preoperative intraocular pressure was 17 mmHg and mean preoperative glaucoma medication requirement was 2.5 topical medications. Twelve-month mean intraocular pressure was 12.8 mmHg (P = 0.07), and mean topical glaucoma medication requirement was 2.3 medications (P = 0.39). All patients were off steroids and anti-inflammatories at the final visit. One patient developed a hyphema requiring anterior chamber washout at 1 week. No other complications occurred. CONCLUSION: The results suggest that combined Trabectome and pars plana vitrectomy seems effective in the management of glaucoma in patients with visually significant retina pathology.

Bilateral angle closure following use of a weight loss combination agent containing topiramate.

PURPOSE: To report a unique case of topiramate-induced bilateral angle closure following ingestion of a recently introduced weight loss medication containing topiramate, and to describe its management. METHODS: Case report of a 39-year-old, otherwise healthy woman who experienced decreased vision, bilateral acute angle closure, choroidal thickening as measured with enhanced depth optical coherence tomography imaging, bilateral suprachoroidal effusions, and induced myopia 1 week after starting a weight loss medication, Qysmia, composed of phentermine 3.75 mg and topiramate 23 mg. Treatment was initiated with high-dose intravenous methylprednisolone, intravenous mannitol, topical difluprednate ophthalmic emulsion, atropine sulfate, and the fixed combination of brimonidine and timolol. At the 2-week follow-up visit, vision, intraocular pressure, and angle anatomy had returned to normal and there was resolution of choroidal and ciliary body effusions on ultrasound biomicroscopy. CONCLUSIONS: Bilateral acute angle closure may develop after ingestion of weight loss drugs containing topiramate.

Combined endoscopic vitrectomy with pars plana tube shunt procedure.

PURPOSE: We report a case series of patients with limited fundus view due to advanced and complex anterior segment disease that underwent combined endoscopic vitrectomy and pars plana tube shunt for intraocular pressure (IOP) control. METHODS: The records of 13 eyes of 11 patients operated at Cincinnati Eye Institute from 2006 to 2010 with combined endoscopic pars plana vitrectomy and pars plana tube shunt placement were retrospectively reviewed. Preoperative and postoperative IOP and visual acuity, clinical course and complications were noted. RESULTS: Nine eyes had aniridia, two had chemical burn injury, one had Axenfeld-Rieger syndrome and one had ocular trauma. Median follow-up was 18 months. Preoperative and postoperative mean LogMAR visual acuities were 1.42±0.9 and 1.24±0.7 (p=0.55). Preoperative mean IOP was 23±9 mm Hg and improved to 12±5 mm Hg postoperatively (p<0.0003). No complications were noted. CONCLUSIONS: Endoscopic vitrectomy with pars plana glaucoma tube shunt implantation may be considered in the management of uncontrolled IOP in patients with media opacity. Achieving IOP control prior to attempted anterior segment reconstruction in these severely diseased eyes may increase the success rate and decrease the complexity of subsequent anterior reconstruction procedures.

Incidence and prevalence of glaucoma in severe ocular surface disease.

PURPOSE: To describe the incidence and prevalence of glaucoma in a patient population with severe ocular surface disease (OSD). METHODS: A retrospective case series was compiled from all charts of patients in the Cincinnati Eye Institute/University of Cincinnati and University of Minnesota population with a diagnosis of severe OSD from 1991 to 2003. The incidence and prevalence of glaucoma in the overall patient population were identified, and stratified into disease subgroups. RESULTS: Of the 108 eyes evaluated in this study, 71 were diagnosed with glaucoma. The overall prevalence of glaucoma in patients with severe OSD is 65.7%, with a range from 42.9% to 88.4%. Analysis by subgroup shows the highest percentage of patients with concurrent glaucoma fall into the categories of aniridia and chemical injury, and the lowest was noted in those patients with autoimmune or iatrogenic OSD. Overall, the incidence of glaucoma was 20.4%, with a range of 13.6% to 60%. CONCLUSIONS: Compared with previous studies, our results show a significantly higher prevalence of glaucoma in patients with severe OSD. This information warrants increased attention to treatment and management of OSD and concurrent glaucoma.

Evolving paradigms in the medical treatment of glaucoma.

In the last 5 years, numerous novel ocular hypotensive agents have been introduced for the control of intraocular pressure (IOP). Clinicians now have more options than ever in medical therapy for the treatment of glaucoma and ocular hypertension. When selecting an ocular hypotensive medication for their patients, clinicians should consider not only the IOP-lowering efficacy of an agent but also the ability of the drug to achieve target levels of IOP that are low enough to stop the progression of glaucomatous damage. Other considerations should include how well the drug controls diurnal IOP, the likelihood of serious adverse events, the versatility of the medication for use as an adjunctive agent, as well as other potential attributes (e.g., neuroprotection).