ABSTRACT
PRECIS: In our case series, the three-year failure for PGI implantation was 14.6%. At three years post-operatively, there was a significant reduction in mean intraocular pressure and number of glaucoma medications used. PURPOSE: To determine 3-year efficacy and safety of the PAUL Glaucoma Implant (PGI), a novel glaucoma tube shunt in patients with glaucoma. METHODS: Retrospective review of all patients who had undergone PGI implantation in a single tertiary institution in Singapore between May 1, 2017, and Jan 1, 2022. Data was extracted from electronic health records (Computerized Patient Support System 2 and Epic). Primary outcome measure was failure, defined as IOP ≥18 mmHg or ≤6 mmHg 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 the absence of failure without medications at 36 months, and qualified success similarly, but with medications. Post-operative mean IOP, mean number of IOP-lowering medications used and visual acuity were also assessed. RESULTS: Forty-eight eyes in 48 patients were identified. Thirty-one patients (64.6%) had primary open angle and angle closure glaucoma, and 18 (37.5%) had previous existing tube implants or trabeculectomy. At 3 years post-operatively, 7 cases (14.6%) fulfilled criteria for failure and 36 (75%) met criteria for complete success. Mean IOP at 36 months was 14.9±4.11 mmHg, from mean pre-operative IOP of 20.6±6.13 mmHg ( P <0.001). Mean number of IOP-lowering medications used was reduced from 3.13±0.959 pre-operatively to 0.167±0.476 at 36 months ( P <0.001). The most common post-operative complication was hypotony (n=17, 35.4%), of which majority were self-limiting, followed by hyphema (n=5, 10.4%) and tube exposure (n=4, 8.3%). CONCLUSION: The PGI demonstrated sustained IOP reduction and a reduction of medication burden at 3 years post-operatively.
