Trends and Usage Patterns of Minimally Invasive Glaucoma Surgery in the United States

Yang, Shuang-An; Mitchell, William; Hall, Nathan; Elze, Tobias; Lorch, Alice C.; Miller, Joan W.; Zebardast, Nazlee

doi:10.1016/j.ogla.2021.03.012

Cited by 59 publications

(41 citation statements)

References 32 publications

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“…In contrast, by 2019 when the present study was designed there were several MIGS options available to patients and surgeons with increasing adoption. 3 In this evolving environment, execution of a trial where many patients would be randomized to a “no treatment” (aside from cataract surgery) control would have faced increased unwillingness of patients to participate and would arguably be less ethically sound given the many new treatment options available for mild to moderate glaucoma.…”

Section: Discussionmentioning

confidence: 99%

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Gallardo¹,

Pyfer²,

Vold³

et al. 2022

OPTH

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Purpose To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Setting Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Methods Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. Results A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (−35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (−80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6–18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Conclusion Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

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Section: Discussionmentioning

confidence: 99%

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Gallardo¹,

Pyfer²,

Vold³

et al. 2022

OPTH

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“…The iStent ® trabecular micro-bypass stent (Glaukos Corporation, San Clemente, CA, USA) was the first MIGS device to gain approval by the US Food and Drug Administration (FDA). 6 , 7 A recent study of data from the IRIS ® registry by Yang et al 8 showed that iStent procedures nearly tripled from 2013 to 2018, accounting for 43.7% of all US glaucoma surgeries (MIGS or otherwise) by 2017. Another study by Yang et al 9 from over 200,000 eyes in the IRIS ® registry from 2013 to 2018 found iStent was the most commonly performed MIGS procedure, with usage primarily in patients with normal tension glaucoma (NTG) or POAG.…”

Section: Introductionmentioning

confidence: 99%

Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension

Clement¹,

Howes²,

Ioannidis³

et al. 2022

OPTH

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Purpose To evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject ® ) with phacoemulsification. Materials and Methods This multicenter retrospective study of iStent inject implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥3 IOP-lowering medications; IOP ≤15 mmHg or ≤18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries. Results A total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4±4.6 mmHg to 13.9±3.5 mmHg; p<0.001), and 70.3% of eyes achieved IOP of ≤15 mmHg (versus 49.1% preoperatively; p<0.001). The mean medication burden decreased by 68.5% (from 1.51±1.17 to 0.48±0.89 medications; p<0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p<0.001), while 6.2% of eyes were on ≥3 medications (versus 22.3% preoperatively; p<0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13–22% for IOP (p<0.05 for all) and 42–94% for medication (p<0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years. Conclusion In this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment.

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“…The VF pattern layout was divided into 10 subfields (five per hemifield) based on the characteristics of glaucomatous VF defect. Regions were outlined as superior central (1) or inferior central (2); superior paracentral (3) or inferior paracentral (4); superior arcuate 1 (5) or inferior arcuate 1 (6); superior arcuate 2 (7) or inferior arcuate 2 (8); and superior nasal (9) or inferior nasal (10). Regional analyses of the subfields were performed using total deviation (TD), total deviation probability (TDP), pattern deviation (PD), and pattern deviation probability (PDP).…”

Section: Discussionmentioning

confidence: 99%

“…3-7, In recent years, minimally invasive glaucoma surgery (MIGS) combined with cataract surgery has risen in popularity as an alternative to reduce eye drop burden or replace more invasive and complicated glaucoma surgeries. [8][9][10][11] MIGS is aptly named given the micro incisional, conjunctival sparing, ab interno approach typically employed. 12 Several different types of MIGS interventions have been developed and target various outflow mechanisms.…”

Section: Introductionmentioning

confidence: 99%

Clinical and Visual Field Outcomes Following Minimally Invasive Glaucoma Surgery Combined with Cataract Surgery

Turner¹,

Taha²,

Yonamine³

et al. 2022

OPTH

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Purpose To determine the change in Humphrey visual field and clinical parameters after minimally invasive glaucoma surgery combined with cataract surgery. Patients and Methods Patients undergoing minimally invasive glaucoma surgery combined with cataract surgery in a multicenter retrospective case series between 2013 and 2021 with reliable preoperative and 12 to 18 month postoperative visual field measurements were included. Devices included iStent, XEN, and Hydrus. Clinical parameters were compared with a generalized linear model with generalized estimating equations between preoperative and postoperative visits including best corrected visual acuity, intraocular pressure, number of glaucoma medications and visual fields. Visual field metrics included mean deviation (MD), pattern standard deviation (PSD), visual field index (VFI), and Collaborative Initial Glaucoma Treatment Study (CIGTS) score of total deviation probability and pattern deviation probability. Results Forty-four eyes from 39 patients were included. During the follow up period, visual acuity improved from 0.23±0.17 to 0.10±0.14 logMAR (mean ± standard deviation, p <0.001), number of glaucoma medications was reduced from 2.68±1.06 to 1.46±1.32 ( p <0.001), and intraocular pressure decreased from 17.08±4.23 mmHg to 14.92±3.13 mmHg ( p =0.003). Differences across devices were negligible. The only significant difference was a greater reduction in number of glaucoma medications in the XEN group ( p <0.001). There were no significant changes in the global parameters of VFI, MD, PSD, or CIGTS. Conclusion Overall, minimally invasive glaucoma surgery combined with cataract surgery appears to be effective at stabilizing visual field function, reducing intraocular pressure, reducing number of glaucoma medications, and improving visual acuity over a 12 to 18 month follow-up period across MIGS devices.

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Trends and Usage Patterns of Minimally Invasive Glaucoma Surgery in the United States

Cited by 59 publications

References 32 publications

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension

Clinical and Visual Field Outcomes Following Minimally Invasive Glaucoma Surgery Combined with Cataract Surgery

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