Abstract
Purpose :
A prospective interventional study evaluating the efficacy of novel biomaterial STAR, (Miniject) within the supraciliary space to facilitate IOP lowering in Primary Open Angle Glaucoma (POAG). The suprachoroidal space has been known for over a century, yet its utility in more recent times has been mired in controversy since the withdrawal of Cypass due its safety profile. Minimally invasive glaucoma surgery has largely concentrated innovation through interventions targeting the trabecular meshwork. However, the suprachoroidal space provides an alternative route through a pressure independent unconventional pathway accounting for up to 40% of aqueous humour drainage.
Methods :
Pseudophakic patients with a diagnosis of POAG on 2-3 medications were recruited between June 2022- February 2023 at St Thomas’ Eye Research Department. Patients were excluded if they had secondary/angle-closure glaucoma. All eligible participants had baseline screening and a total of 31 patients were recruited. Primary outcomes included tonographic outflow facility and IOP reduction. Secondary outcomes included safety profile, change in number of medications, medication free status, endothelial cell count and aqueous flare. Paired samples T-Test were performed to evaluate significance of outcomes from baseline to 3 months.
Results :
Of the 31 participants, 73% were female, mean age was 74, 53% were Caucasian and 40% Afro-Caribbean. POAG constituted 80% of our cohort. Mean IOP (mmHg) was 18 (SD 3.7) at baseline and 15 (SD 4.9) at 3 months (p=0.003). Tonographic outflow facility (μL/min/mm Hg) at baseline was 0.09 (SD 0.086), at 3 months was 0.11 (SD 0.074) (p= 0.2) At 3 months, 60% of patients were medication free and 72% showed reduction in drop treatment (p<0.001). Endothelial cell count (cells/mm2) was 2002 at baseline and 1977 at 3 months. Aqueous flare (ph/ms) at baseline was 109.2 (SD 83.1) and at 3 months 23.9 (SD 18.4) (p<0.001). With respect to safety profile, 4 patients had hyphema, IOP spike and 1 patient had hypotony.
Conclusions :
This is the first study to assess tonographic outflow facility for the supraciliary Miniject device. Our study demonstrates that supraciliary devices have no effect on trabecular outflow facility, which is an important finding to highlight. The Miniject supraciliary implant is a safe and efficacious device to lower IOP for POAG patients showing an approximate 20% reduction in IOP.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.