Two-Year Outcomes of the Paul Glaucoma Implant for Treatment of Glaucoma

Purpose: To determine 2-year efficacy of the PAUL Glaucoma Implant (PGI), a novel glaucoma tube shunt in patients with advanced glaucoma. Participants: Patients with glaucoma refractory to maximum medical therapy or previous failed glaucoma surgery. Methods: Retrospective review of all patients who had underwent PGI implantation in a single tertiary institution between May 1, 2017 and March 30, 2021. Main Outcome Measures: Primary outcome measure was failure defined as intraocular pressure (IOP) >18 mm Hg or <6 mm Hg on 2 consecutive visits after 3 months, reoperation for IOP-related indication, explantation of implant or loss of light perception vision. Complete success was defined as unmedicated IOP <= 18 mm Hg or >= 6 mm Hg in the absence of failure. Results: Forty-five eyes in 45 patients were identified, with mean follow-up duration of 24.9 +/- 2.0 months. Thirty patients (66.7%) had primary glaucoma and 11 (24.4%) with previous glaucoma surgery. At 2 years following surgery, 8 eyes (17.8%) fulfilled the failure criteria with 32 eyes (71.1%) achieving complete success. Compared with mean medicated preoperative IOP (19.8 +/- 6.3 mm Hg), postoperative IOP at 24 months was 13.9 +/- 3.7 (P<0.01). Mean number of medications decreased from 3.2 +/- 0.8 preoperatively to 0.29 +/- 0.65 at 24 months (P<0.01). Significant complications included self-limiting shallow anterior chamber (n=10; 22.2%), hypotony requiring intervention (n=4; 8.9%) and tube occlusion (n=4; 8.9%). Conclusions: The PGI was able to achieve sustained IOP reduction with reduction of medications at 2 years postsurgery in patients with advanced glaucoma.