Matched Cohort Study of Cataract Surgery With and Without Trabecular Microbypass Stent Implantation in Primary Angle-Closure Glaucoma

Salimi, Ali; Abu-Nada, Mohamed; Harasymowycz, Paul

doi:10.1016/j.ajo.2020.12.032

Cited by 14 publications

(10 citation statements)

References 55 publications

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“…Another explanation could be the differences in surgical techniques. As detailed in our previous studies of the iStent inject, [ 15 – 18 ] the stents were implanted into the trabecular meshwork, adjacent to the collector channels (identified and marked preoperatively, as described in “ Methods ”), to ensure maximal proximity of the stents to the collector channel ostia. Our rationale is based on the knowledge that collector channel ostia provide the shortest pathway to aqueous veins and that the collector channels in these areas are more dilated, which collectively can allow for the most efficient outflow [ 68 – 70 ].…”

Section: Discussionmentioning

confidence: 99%

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Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

2021

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Background The short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up. Methods This longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events. Results A total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease. Conclusions Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

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Section: Discussionmentioning

confidence: 99%

“…The surgical technique has been described in detail elsewhere [ 15 – 18 ]. In short, two areas with the greatest degree of trabecular meshwork pigmentation or with evidence of focal blood reflux, separated by at least two clock hours, were preoperatively marked at the corneal limbus.…”

Section: Methodsmentioning

confidence: 99%

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

2021

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“…This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up. [24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] Both iStent and iStent inject are implanted ab internally and enhance the physiologic trabecular outflow pathway of aqueous humor, thereby decreasing IOP. Targeting the natural outflow pathway helps avoid the risks of suprachoroidal, bleb-forming, subconjunctival, and/or ab externo procedures.…”

Section: Introductionmentioning

confidence: 99%

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Singh¹,

Sarkisian²,

Hornbeak³

et al. 2021

OPTH

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Purpose: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject ® with cataract surgery (INJ) vs cataract surgery alone (CS). Materials and Methods: Prospective, 3:1 randomized, single-masked, concurrentlycontrolled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP <25mmHg, Mid-DIOP ≥25 to <30 mmHg, High-DIOP ≥30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥3 medications). Results: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. Conclusion: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases.

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“…In vitro perfusion model study did not demonstrate significant difference in outflow facility increase between the two stents. 31 A subgroup analysis by Salimi et al 48 shows no significant difference was found between the two generations in terms of IOPR and medication use in eyes with primary angle closure glaucoma.…”

Section: Discussionmentioning

confidence: 98%

Comparison of Hydrus and iStent microinvasive glaucoma surgery implants in combination with phacoemulsification for treatment of open-angle glaucoma: systematic review and network meta-analysis

Guo

Hong

et al. 2022

BMJ Open

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ObjectivesTo compare the efficacy and safety of two Schlemm’s canal-based microinvasive glaucoma surgery (MIGS) devices, the Hydrus Microstent and the iStent Trabecular Bypass combined with phacoemulsification for treatment of open-angle glaucoma.DesignSystematic review and network meta-analysis.MethodsLiterature searches were conducted on PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov to identify randomised controlled trials (RCTs) assessing the Hydrus or the iStent implantation combined with phacoemulsification for treatment of open-angle glaucoma until September 2020. Risk of bias was assessed using a six-item modified Jadad scale. Effects were estimated using the intraocular pressure (IOP) reduction (IOPR), the percentage of IOPR and the proportion of medication-free patients at follow-up end. Safety was estimated using the proportions of adverse events. The network meta-analysis was conducted within a Bayesian framework using the Markov Chain Monte Carlo method in ADDIS software.ResultsSix prospective RCTs comprising 1397 patients were identified. Regarding the absolute value and the percentage of IOPR, the Hydrus and 2-iStent implantation combined with phacoemulsification were significantly more effective than phacoemulsification alone. Rank probability analysis revealed the Hydrus might be the best choice to lower IOP. There was no significant difference in the proportion of medication-free patients among groups. The Hydrus and 2-iStent implantation had a higher probability to achieve the medication-free status versus the 1-iStent implantation and phacoemulsification alone. Overall safety profiles were good for each device with the focal peripheral anterior synechiae more frequently reported in Hydrus eyes.ConclusionsThe Hydrus implantation may have a slight advantage over the 1-iStent or 2-iStent implantation in combination with phacoemulsification to treat open-angle glaucoma. Our findings might be of some uncertainty due to the limited included data. Further studies are needed to investigate whether our findings are robust, including high-quality RCTs to directly compare these MIGS devices.

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Matched Cohort Study of Cataract Surgery With and Without Trabecular Microbypass Stent Implantation in Primary Angle-Closure Glaucoma

Cited by 14 publications

References 55 publications

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

Comparison of Hydrus and iStent microinvasive glaucoma surgery implants in combination with phacoemulsification for treatment of open-angle glaucoma: systematic review and network meta-analysis

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