Combined Ab interno viscocanaloplasty (ABiC) in open-angle glaucoma: 12-month outcomes

Gillmann, Kevin; Aref, Amr; Niegowski, Laëtitia Jessy; Baumgartner, J.-M.

doi:10.1007/s10792-021-01891-1

Cited by 14 publications

(12 citation statements)

References 21 publications

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“… 24 , 25 Another canaloplasty procedure—ab interno canaloplasty, or ABiC—has been shown to reduce mean IOP by 25–40% and mean medication use by 61–97% in various studies. 26–29 Similarly, trabeculotomy procedures (TRAB360 [an OMNI precursor] and gonioscopy-assisted transluminal trabeculotomy [GATT]) have been reported in various studies to reduce mean IOP by 28–44% and medication use by 28–82% as standalone procedures, 30 – 37 and GATT lowers mean IOP by 29–67% and medications by 45–93% when combined with phacoemulsification. 30 , 35 , 38 , 39 …”

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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“…Hughes and Traynor reported a mean IOP reduction of 36% (from baseline 24.5 ± 8 to 15.8 ± 2.5) and a 32% reduction of glaucoma medications (from baseline 2.5 ± 1.3 to 1.7 ± 1.5) when performing ABiC with the Visco360 or the OMNI Surgical System [46]. Other authors also reported similar results with ABiC as a standalone procedure or in combination with phacoemulsification [56][57][58].…”

Section: Canaloplasty Ab Interno (Abic)mentioning

confidence: 85%

Canaloplasty in the spotlight: surgical alternatives and future perspectives

Beres

Scharioth

2022

rjo

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“… 18 , 19 Among studies of 12–24 months’ duration of canaloplasty performed with the iTrack ® microcatheter (Nova Eye Medical, Fremont, CA; previously reported as ab interno canaloplasty, or ABiC) in eyes with open-angle glaucoma, mean IOP reductions of 25–40% have been reported, with 78.4% achieving IOP reductions of ≥20% from baseline; mean medication reductions of 39–97% and medication-free rates of 25–80% have also been reported. 20–25 …”

Section: Discussionmentioning

confidence: 99%

Interim Analysis of STREAMLINE® Surgical System Clinical Outcomes in Eyes with Glaucoma

Lazcano‐Gomez¹,

Garg²,

Yeu³

et al. 2022

OPTH

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Purpose To characterize the clinical outcomes of a novel ab interno minimally invasive procedure with the STREAMLINE ® Surgical System for creation of incisional goniotomies and canal of Schlemm viscodilation in eyes with mild to severe primary open-angle glaucoma (POAG). Methods In a prospective, single-arm, first-in-human case series, 20 eyes of 20 subjects with mild to severe POAG underwent creation of incisional goniotomies and canal of Schlemm viscodilation following phacoemulsification cataract extraction after washout of all intraocular pressure (IOP)-lowering medications. The angle surgery portion was performed with a single-use handpiece tipped with a microcannula that creates precise goniotomies through the trabecular meshwork into the canal of Schlemm and delivers a small volume of ophthalmic viscosurgical device directly into the canal via precise catheterization. Outcomes in this interim analysis included mean reduction in IOP and medications through 6 months of follow-up, as well as the proportion of eyes achieving IOP reduction ≥20% from baseline. Results At month 6, mean IOP reduction of ≥20% from baseline was achieved in 89.5% of eyes (17/19). Mean (standard deviation) medicated IOP at screening was 16.3 (3.6) mmHg and unmedicated baseline IOP (after washout) was 23.5 (2.5) mmHg. Mean IOP was significantly reduced from baseline through 6 months of follow-up to 14.7 (2.4) mmHg ( p <0.001), representing an IOP reduction of 8.8 mmHg (36.9%). Overall, 57.9% (11/19) of eyes decreased dependence on IOP-lowering medications by at least one medication, and 42.1% (8/19) were medication free. Mean medication use was reduced from 2.0 (0.8) at screening to 1.1 (1.1) at 6 months ( p <0.001). Three eyes had transient IOP spikes treated with topical medications. Conclusion The creation of incisional goniotomies and canal of Schlemm viscodilation safely and effectively reduced IOP and the need for IOP-lowering medications by both clinically and statistically significant magnitudes in eyes with mild to severe POAG undergoing concomitant phacoemulsification cataract extraction through the first 6 months of follow-up.

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Combined Ab interno viscocanaloplasty (ABiC) in open-angle glaucoma: 12-month outcomes

Cited by 14 publications

References 21 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

Canaloplasty in the spotlight: surgical alternatives and future perspectives

Interim Analysis of STREAMLINE® Surgical System Clinical Outcomes in Eyes with Glaucoma

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