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Glaucoma Surgery Comparison: SIBS Microshunt Versus Gelatin 45 µm Microstent Versus Trabeculectomy as Primary
James J Armstrong1, Ticiana De Francesco2, Henny J Beckers3
1From the Department of Ophthalmology (J.J.A.), Schulich School of Medicine, Western University, London, Canada.
Purpose:
Compare surgical success, risk factors, and postoperative course of the SIBS microshunt, gelatin 45 μm microstent, and trabeculectomy with mitomycin C (MMC) as a primary surgical intervention in patients with glaucoma. We present a multicenter,12-month, retrospective, nonrandomized, interventional case series.
Design:
Multicenter,12-month, retrospective, nonrandomized, interventional case series.
Methods:
Consecutive patients with glaucoma on maximally tolerated medical therapy received either primary SIBS microshunt, gelatin 45 µm microstent, or trabeculectomy with MMC as a stand-alone procedure at one of six participating centers (Canada, Italy, the Netherlands, Belgium, Singapore, Dominican Republic) from August 2015 to August 2020. Main outcome measures were proportion of eyes at 12-months with (1) no two consecutive intraocular pressures (IOPs) > 17 mm Hg or clinical hypotony (IOP < 6 mm Hg with a loss of> 2 lines of vision), without (complete) or with (qualified) glaucoma medications; and (2) ≥20% reduction from baseline IOP. Secondary outcomes included IOP thresholds of 14 and 21 mm Hg, median IOP, medications, risk factors, postoperative interventions, complications, and reoperations.
Results:
Records from 577 eyes from 521 patients with SIBS microshunt (n = 235), gelatin 45 μm microstent (n = 201), or trabeculectomy (n = 141) were included. Baseline decision IOP was lower in the SIBS group, and baseline number of glaucoma medications was also lower in the SIBS and trabeculectomy groups. After 12-month follow-up, complete success occurred in 68.8% of patients with SIBS microshunt, 46.2% with gelatin 45 μm microstent, and 58.0% with trabeculectomy (P = .0002). Qualified success occurred in 89.7%, 70.1%, and 83.6% of eyes, respectively (P = .0002). In the multivariate analysis, eyes receiving a gelatin 45 μm microstent relative to SIBS microshunt (hazard ratio [HR] 2.0; 95% confidence interval [CI] 1.5-2.7), trabeculectomy relative to SIBS microshunt (HR 1.6; 95% CI 1.2-2.2), or intraoperative MMC dose less than 0.4 mg/mL (HR 1.5; 95% CI 1.1-2.0) was significantly associated with failure. Complications occurred in 33.6%, 42.8% and 56% of eyes (P = .0001); needling in 12.3%, 29.9% and 22% (P < .0001); revisions in 10.6%, 8.5% and 8.5% (P = .68); and reoperations in 5.5%, 13.9% and 7.8% (P < .001) with SIBS microshunt, gelatin 45 μm microstent, or trabeculectomy, respectively.
Conclusions:
Overall, patients with the SIBS microshunt achieved higher success rates compared to both trabeculectomy and the gelatin 45 μm microstent group, with fewer postoperative complications, interventions, and reoperations for glaucoma.
Insights
The SIBS microshunt demonstrated superior surgical success rates for glaucoma compared to trabeculectomy and the gelatin microstent. Patients receiving the SIBS microshunt experienced fewer complications and reoperations post-surgery.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Device Technology
Background:
- Glaucoma management often requires surgical intervention to lower intraocular pressure (IOP).
- Several surgical options exist, including microshunts and traditional trabeculectomy with mitomycin C (MMC).
- Comparative data on newer microshunts versus established procedures is crucial for clinical decision-making.
Purpose of the Study:
- To compare the surgical success, risk factors, and postoperative outcomes of the SIBS microshunt, gelatin 45 μm microstent, and trabeculectomy with MMC.
- To evaluate these interventions as primary surgical treatments for patients with glaucoma.
Main Methods:
- A multicenter, 12-month, retrospective, nonrandomized, interventional case series.
- Inclusion of 577 eyes from 521 patients undergoing primary SIBS microshunt, gelatin 45 μm microstent, or trabeculectomy with MMC.
- Primary outcome: proportion of eyes achieving target IOP control (no two consecutive IOPs > 17 mm Hg or hypotony) at 12 months, with or without medications.
Main Results:
- The SIBS microshunt group showed significantly higher complete success rates (68.8%) compared to gelatin microstent (46.2%) and trabeculectomy (58.0%) (P = .0002).
- Qualified success rates were also highest for SIBS microshunt (89.7%) versus gelatin microstent (70.1%) and trabeculectomy (83.6%).
- The gelatin microstent and trabeculectomy were associated with a higher risk of failure compared to the SIBS microshunt; SIBS also had fewer complications and reoperations.
Conclusions:
- The SIBS microshunt achieved superior surgical success rates compared to both trabeculectomy and the gelatin 45 μm microstent.
- Patients treated with the SIBS microshunt experienced fewer postoperative complications, interventions, and reoperations.
- The SIBS microshunt represents a highly effective primary surgical option for glaucoma management.
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