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Abstract Introduction This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. Methods This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. Results A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years postoperative, mean IOP reduced by 12.9–19.0% (p

Abstract Introduction This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a single trabecular microbypass stent (iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angle glaucoma in Korean patients. Methods This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation iStent® implantation with phacoemulsification by a single surgeon with 5 years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18 mmHg without medication, ≤ 15 mmHg without medication, and ≤ 18 mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. Results The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7 mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year 5. At 3 and 5 years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5 years. At years 3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18 mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18 mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN 45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction. Conclusion This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP.

Abstract Introduction The purpose of this study was to compare the surgical outcomes between ab interno trabeculotomy (LOT) and iStent inject W implantation (iStent) both combined with cataract surgery, matching the background factors including age, intraocular pressure (IOP), medication score, central corneal thickness (CCT), and axial length. Methods A total of 100 eyes from 75/79 patients with primary open-angle glaucoma were included in the LOT/iStent groups. The background factors were matched between the two groups using the propensity score. Results There were no significant differences in age, IOP, medication score, CCT, and axial length, preoperatively. The postoperative medication scores were 1.3 ± 1.2 and 1.2 ± 1.2 in the LOT and iStent groups. The postoperative IOPs were 12.8 ± 2.8 and 13.1 ± 2.4 mmHg in the LOT and iStent groups, respectively. The changes in the medication score were − 0.64 ± 1.4 and − 0.44 ± 1.6 in the LOT and iStent groups, respectively. The changes in the IOP were − 2.1 ± 3.3 and − 1.5 ± 3.0 mmHg in the LOT and iStent groups, respectively. These values were not significantly different between the two groups. The postoperative IOP and changes in the IOP were significantly associated with preoperative IOP and CCT. There was no significant difference in the occurrence of postoperative complications (hyphema, 11.0% and 6.0%, and transient ocular hypertension, 8.0% and 5.0%, in the LOT and iStent groups, respectively). Conclusion LOT and iStent have similar surgical outcomes with sufficient safety. Postoperative IOP was significantly associated with preoperative IOP and CCT in both groups.

Abstract Introduction This real-world retrospective case series assessed 12-month effectiveness and safety following implantation of iStent® or iStent inject ® trabecular micro-bypass with cataract surgery. Methods Consecutive patients were implanted with either iStent (comprising 1 stent) or iStent inject (comprising 2 stents), together with cataract surgery. Most patients had primary open-angle glaucoma. Effectiveness outcomes through 12 months included intraocular pressure (IOP) and glaucoma medications. Proportional analyses were completed for eyes achieving IOP ≤ 18 mmHg, IOP ≤ 15 mmHg, or IOP reduction ≥ 20% from preoperative; and eyes on 0 medications or ≥ 2 medications. Safety outcomes included adverse events, secondary surgeries, visual acuity, and visual fields. Results This analysis included 137 eyes (67 iStent, 70 iStent inject) with cataract and mild to moderate glaucoma or ocular hypertension. Over 73% of eyes in both groups had early disease, and ~ 22% had prior glaucoma surgery. At 12 months postoperatively, mean IOP decreased from 18.4 ± 4.2 mmHg to 14.2 ± 2.5 mmHg in iStent eyes (p

Abstract Introduction In this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject® trabecular micro-bypass device with concomitant cataract surgery. Methods Performance outcomes included intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving an IOP of

Introduction: The purpose of this study was to compare the surgical outcomes between ab interno trabeculotomy (LOT) and iStent inject W implantation (iStent) both combined with cataract surgery, matching the background factors including age, intraocular pressure (IOP), medication score, central corneal thickness (CCT), and axial length., Methods: A total of 100 eyes from 75/79 patients with primary open-angle glaucoma were included in the LOT/iStent groups. The background factors were matched between the two groups using the propensity score., Results: There were no significant differences in age, IOP, medication score, CCT, and axial length, preoperatively. The postoperative medication scores were 1.3 ± 1.2 and 1.2 ± 1.2 in the LOT and iStent groups. The postoperative IOPs were 12.8 ± 2.8 and 13.1 ± 2.4 mmHg in the LOT and iStent groups, respectively. The changes in the medication score were  - 0.64 ± 1.4 and  - 0.44 ± 1.6 in the LOT and iStent groups, respectively. The changes in the IOP were  - 2.1 ± 3.3 and  - 1.5 ± 3.0 mmHg in the LOT and iStent groups, respectively. These values were not significantly different between the two groups. The postoperative IOP and changes in the IOP were significantly associated with preoperative IOP and CCT. There was no significant difference in the occurrence of postoperative complications (hyphema, 11.0% and 6.0%, and transient ocular hypertension, 8.0% and 5.0%, in the LOT and iStent groups, respectively)., Conclusion: LOT and iStent have similar surgical outcomes with sufficient safety. Postoperative IOP was significantly associated with preoperative IOP and CCT in both groups., (© 2023. The Author(s).)

Introduction: Primary open-angle glaucoma is estimated to affect 3% of the population aged 40-80 years. Trabeculectomy is considered the gold standard in surgical management of glaucoma; however, it is a technically complex procedure that may result in a range of adverse outcomes. Device-augmented, minimally invasive procedures (micro-invasive glaucoma surgeries, MIGS) have been developed aiming for safer and less invasive intraocular pressure (IOP) reduction compared with traditional surgery., Methods: This paper presents results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events. For economic evidence, trials on cost-effectiveness, cost-utility, cost-benefit, cost-consequences, cost-minimization, cost of illness, and specific procedure costs were included. Risk of bias was assessed for clinical studies using the Cochrane Risk of Bias tool., Results: A total of nine RCTs (seven iStents ® , one Hydrus ® , and one CyPass ® ), seven non-RCTs (three iStent ® , three CyPass ® , and one Hydrus ® ), and 23 economic studies were analyzed. While various forms of trabeculectomy can achieve postoperative IOP of between 11.0 and 13.0 mmHg, MIGS devices described in this review were typically associated with higher postoperative IOP levels. In addition, MIGS devices may result in increased hypotony rates or bleb needling in subconjunctival placed devices, requiring additional medical resources to manage. There is limited available evidence on the cost-effectiveness of MIGS and therefore it remains unclear whether the cost of using MIGS is outweighed by cost savings through decreased medication and need for further interventions., Conclusion: Larger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost., Funding: Santen GmbH, Germany.