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

Abstract

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.

Ab-Interno Canaloplasty and Ab-Interno Canaloplasty/Trabeculotomy in Glaucoma Patients Using the OMNI Surgical System

“…The microcatheter is firmly integrated into the system, as is a reservoir that holds the viscoelastic (Figure 1). The surgical procedure itself has been well described in a number of previous publications [4,5,15,[17][18][19][20]. Ab-Interno Canaloplasty and Ab-Interno Canaloplasty/Trabeculotomy in Glaucoma Patients… DOI: http://dx.doi.org/10.5772/intechopen.110888…”

“…There is limited data available on the performance of OMNI Surgical System in pseudoexfoliation glaucoma and pigmentary glaucoma [5]. One retrospective observation included only six patients diagnosed with pseudoexfoliation and one with pigmentary glaucoma [32] and another clinical study includes nine and one patients, respectively [20]. In general, the demographics of these patients were unremarkable compared with the pooled study populations.…”

“…The first final 12-month analysis of a clinical trial was published in 2022 [20]. The GEMINI study was a prospective, multicenter, interventional, single-arm clinical study of patients with mild-moderate OAG undergoing 360° canaloplasty followed by 180° trabeculotomy with the OMNI Surgical System at the time of phacoemulsification.…”

„Minimally invasive glaucoma surgery“ – Kammerwinkelbasierte Verfahren im Vergleich

“…Auch eine Kombination mit der Kataraktchirurgie ist sehr gut möglich und lässt sich ohne größeren Aufwand in die Operationsroutine einführen. Auch bei der Medikamentenreduktion liegen die Werte tendenziell etwas höher in der kombinierten Operation (Medikamentenreduktion um 0,8 bis 1,6 nach 12 Monaten sowie 0,8 bis 1,0 nach 18 Monaten vs. 1,3 bis 1,5 nach 12 Monaten sowie 1,4 bis 1,5 nach 24 Monaten) [33][34][35][36][37].…”

Canaloplasty in the spotlight: surgical alternatives and future perspectives

“…The patients underwent 360-degree canaloplasty and 180-degree trabeculotomy using the OMNI Surgical System in combination with phacoemulsification. The authors report that 84.2% of the eyes achieved IOP reductions greater than 20% from baseline and 80% of eyes were medication-free at 12-month follow-up [ 59 ]. In the ROMEO Study, patients underwent the same procedure as in the GEMINI Study.…”