PurposeTo evaluate the safety and efficacy of the iStent trabecular microbypass stent in combination with cataract surgery in patients with open-angle glaucoma (OAG).MethodsRetrospective, consecutive case series from October 2012 to December 2015 with no exclusion criteria. The series comprised of 350 eyes with OAG and cataract. Data were collected both preoperatively and postoperatively at day 1 week 1, months 1, 3, 6, 12, 18, and 24. Data included intraocular pressure (IOP), number of glaucoma medications, visual acuity, the incidence of postoperative IOP pressure spikes of greater than ≥15 mmHg at any time point, and need for additional surgery.ResultsThe mean preoperative IOP was 19.13±6.34 mmHg. At 2 years postoperation, mean IOP was 15.17±3.53 mmHg (P<0.0001). The mean number of glaucoma medications was 1.19±1.00 preoperatively and 0.61±0.96 (P<0.0001) at 2 years postoperation. At 1 day postoperatively, 31 eyes (12.4%) experienced an IOP increase of 15 mmHg above their baseline IOP that responded to topical therapy. Two patients required additional tube shunt surgery.ConclusionThe insertion of the iStent trabecular microbypass stent in combination with cataract surgery effectively lowers IOP in OAG patients. The magnitude of IOP reduction was more significant in patients with higher preoperative pressure. Medication use was also significantly reduced postoperatively. The safety profile appears favorable with a low rate of IOP spikes and only two eyes (<1%) requiring additional surgery.

Glaucoma is a chronic, debilitating disease and a leading cause of global blindness. Despite treatment efforts, 10% of patients demonstrate loss of vision. In the US, [ 80% of glaucoma cases are classified as open-angle glaucoma (OAG), with primary open-angle (POAG) being the most common. Although there has been tremendous innovation in the surgical treatment of glaucoma as of late, two clinical variants of OAG, normaltension glaucoma (NTG) and severe POAG, are especially challenging for providers because patients with access to care and excellent treatment options may progress despite achieving a ''target'' intraocular pressure value. Additionally, recent research has highlighted the importance of nocturnal IOP control in avoiding glaucomatous disease progression. There remains an unmet need for new treatment options that can effectively treat NTG and severe POAG patients, irrespective of baseline IOP, while overcoming adherence limitations of current pharmacotherapies, demonstrating a robust safety profile, and more effectively controlling nocturnal IOP.

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Purpose: To investigate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in eyes with primary open-angle glaucoma (POAG). Setting: Private practice; Sioux Falls, South Dakota. Design: Retrospective, consecutive case series. Methods: This case series included eyes implanted with a single trabecular microbypass stent in combination with phacoemulsification in patients with mild to severe POAG. Data were collected preoperatively and at day 1, week 1, month 1, and up to 6 years postoperatively. Primary outcome measures included mean intraocular pressure (IOP) and number of glaucoma medications. Safety was noted by assessing the incidence of IOP spikes and need for additional surgery. Results: The study comprised 411 eyes. Mean IOP was reduced to 14.9±4.2 mmHg compared to 18.8±5.6 mmHg at baseline at 6 years postoperative. The mean number of medications was reduced to 1.2±1.0 from 1.4±1.1 at baseline. In eyes with severe stage of disease, there was a mean IOP reduction >6 mmHg at 6 years postoperative. Eyes with baseline IOP ≥18 mmHg achieved a more robust reduction in IOP. Fifteen eyes underwent a secondary glaucoma procedure. There were no intra-or postoperative complications. Conclusion: Trabecular microbypass stent implantation in combination with cataract surgery provides a sustained IOP reduction in eyes with mild-to-severe POAG. The degree of IOP reduction was more significant in eyes with higher baseline IOP and severe stage of disease.

Trabecular microbypass stent implantation during cataract surgery safely and effectively lowers IOP and medication use in patients with severe primary open-angle glaucoma.

Trabecular microbypass stent implantation during cataract surgery safely and effectively lowered IOP and medication use in patients with mild to severe PXG.

Purpose: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. Design: Prospective, open-label, randomized, single-site study. Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of −10 mmHg in one eye (study eye) worn overnight for 7 consecutive days. Methods: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period. Results: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable. Conclusion: The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.