Long-term Outcomes of SIBS Microshunt in Cases of Refractory and Non-Refractory Glaucoma

Authors: Anastasiya Vinokurtseva¹, Ticiana De Francesco², Matthew B. Schlenker¹, Iqbal Ike Ahmed¹. ¹Prism Eye Institute; University of Toronto, ²Hospital de Olhos Leiria de Andrade.

Author Disclosures: A. Vinokurtseva: None. T. De Francesco: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Sight Sciences, Allergan, ViaLase, Elios, Iantrek. Any direct financial payments including receipt of honoraria; Description of relationship(s); Consultant fees, honoraria. M.B. Schlenker: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Santen Pharmaceutical Co., Ltd, Alcon, Aequus Pharmaceuticals, Johnson & Johnson Vision, Labtician Thea, Light Matter Interaction Inc. Any direct financial payments including receipt of honoraria; Description of relationship(s); Consultant fees, honoraria. I. Ahmed: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Aequus, Ace Vision, Aerie Pharamceuticals, Akorn, Alcon, Allergan, Aquea Health Inc, ArcScan, Avellino Lab USA Inc, Avisi, Bausch Health, Beaver Visitec, Beyeonics, Bionode, Carl Zeiss Meditec,, Centricity Vision Inc, CorNeat Vision, Custom Surgical, Elios Vision, ElutiMed, Equinox, eyeFlow Inc, Exhaura Ltd, Genentech, Glaukos, Gore, Heine, Heru, Iantrek, InjectSense, Iridex, iCare, iStar,, Ivantis, Johnson & Johnson Vision, Labtician Thea, LayerBio, Leica Microsystems, Life Long Vision, Long Bridge Medical Inc, MicroOptx, MST Surgical, Myra Vision, New World Medical, NovaEye, Ocular Insturments, Ocular Therapeutix, Oculo, Oculus Surgical, Omega Ophthalmics, PolyActiva, PulseMedica, Radiance Therapeutics Inc, Ripple Therapeutics, Sanoculis, Santen, Shifamed LLC,, Sight Sicences, Smartlens Inc, Stroma, Thea Pharma, ViaLase, Visus Therapeutics, Vizzario, VSY Biotechnology, Zilia Inc. Any direct financial payments including receipt of honoraria; Description of relationship(s); Consultant Fees, Speakers Honoraria, Research Support.


Abstract Body: 

Purpose: To compare effectiveness, safety, and risk factors for failure of SIBS microshunt implantation in refractory and non-refractory glaucoma patients. 

Study Design: Multicenter, retrospective, interventional cohort study. 

Methods: Consecutive patients undergoing SIBS microshunt implantation between Aug2015 and Aug2020 at one of 6 participating international centers were included. Refractory status was defined as having previous glaucoma filtering surgery. Primary outcome was surgical success, defined as proportion of eyes at 12-months with (1) no 2 consecutive IOPs >17mmHg or clinical hypotony, without (complete) or with (qualified) glaucoma medications; and (2) ≥20% reduction from baseline IOP (20%IOPR). Secondary outcomes included complete and qualified surgical success with 14mmHg and 21mmHg IOP thresholds, with and without 20%IOPR; median IOP; medications; risk factors for failure; post-operative interventions, complications, and reoperations. 

Results: Records from 200 eyes that received SIBS microshunt with previous glaucoma surgery(n=97) and without(n=103) were included, with 9.2% refractory and 4.9% non-refractory patients undergoing surgery combined with phacoemulsification. Refractory patients were more likely to be younger (82.5% <70) and to have worse pre-operative visual acuity (45.4% >0.4logMAR). After 12-months follow-up, 74.3% of non-refractory eyes and 60.6% of refractory eyes achieved complete surgical success. Risk factors significantly associated with failure were refractory status (HR 3.2; 95%CI 1.8-5.7) and mitomycin (MMC)dose <0.4mg/mL (HR 3.0; 95%CI 1.7-5.2). At 12 months, 55.3% of non-refractory patients were medication-free, compared to 30.9% of refractory patients (OR 2.8; 95%CI 1.5-5.0). Complications of any type occurred in 14.8% of non-refractory and 34.1% of refractory patients. In non-refractory eYes, 10.7% underwent needling, compared to 22.7% in refractory (OR 2.5; 95%CI 1.2-5.3). Non-refractory eyes underwent revision in 10.7% of the cases, compared to 8.2% in refractory eyes; 3.9% of non-refractory and 4.1% of refractory eyes underwent re-operations for glaucoma. 

Conclusions: One-year follow-up data of this cohort showed promising rates of complete and qualified success, with refractory patients having higher failure rates. Non-refractory patients and those receiving >=0.4mg/ml enjoyed significantly higher rates of success (74.3%), with higher medication-free survival (55.3%) and lower rates of complications (14.8%), needling (10.7%), and reoperations (3.9%) compared to refractory eyes.

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