Three-Year Outcomes of the Paul Glaucoma Implant for Treatment of Glaucoma.

PRCIS: In our case series, the 3-year failure for Paul Glaucoma Implant (PGI) implantation was 14.6%. At 3 years postoperatively, there was a significant reduction in mean intraocular pressure (IOP) and the number of glaucoma medications used. OBJECTIVE: To determine the 3-year efficacy and safety of the 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 January 1, 2022. Data were extracted from electronic health records (Computerized Patient Support System 2 and Epic). The primary outcome measure was failure, defined as 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 the absence of failure without medications at 36 months, and qualified success similarly, but with medications. Postoperative 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 postoperatively, 7 cases (14.6%) fulfilled the criteria for failure and 36 (75%) met the criteria for complete success. The mean IOP at 36 months was 14.9 ± 4.11 mm Hg, from the mean preoperative IOP of 20.6 ± 6.13 mm Hg ( P < 0.001). The mean number of IOP-lowering medications used was reduced from 3.13 ± 0.959 preoperatively to 0.167 ± 0.476 at 36 months ( P < 0.001). The most common postoperative complication was hypotony (n = 17, 35.4%), of which the 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 postoperatively.

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.

Case Series of Combined iStent Implantation and Phacoemulsification in Eyes with Primary Angle Closure Disease: One-Year Outcomes.

PURPOSE: To evaluate the safety and efficacy of combined iStent® trabecular micro-bypass device (Glaukos, Laguna Hills, CA) and phacoemulsification in eyes with primary angle closure disease. METHODS: A two-center prospective interventional case series of consecutive patients with primary angle closure (PAC) or primary angle closure glaucoma (PACG) on at least one glaucoma medication, who underwent iStent implantation with cataract surgery. Postoperatively, patients were assessed on days 1 and 7, and months 1, 3, 6, and 12. The intraocular pressure (IOP), glaucoma medication use, visual acuity, and the presence of complications were assessed at each visit. Complete success was defined as IOP reduction of at least 20% without the use of glaucoma medications. RESULTS: Thirty-seven eyes with angle closure disease were included in this study. At 1-year, postoperative mean IOP (14.8 ± 3.94 mmHg) was significantly decreased compared with preoperative medicated (17.5 ± 3.82 mmHg, p = 0.008) and unmedicated (24.6 ± 3.41 mmHg, p < 0.001) IOP. Complete success was achieved in 89.2% of the eyes. The number of glaucoma medications decreased from 1.49 ± 0.77 to 0.14 ± 0.48 (p < 0.001). Preoperative medicated IOP was a risk factor for failure (hazard ratio 3.45, 95% confidence interval 1.52-7.85, p = 0.003), after adjustment for age, gender, and race. The most common postoperative complications were iStent occlusion with iris (27.0%) and hyphema (18.9%). There were no sight-threatening intraoperative or postoperative complications. CONCLUSION: Combined iStent implantation with cataract surgery was effective in lowering the IOP and the number of glaucoma medications for at least 12 months, with a favorable safety profile. FUNDING: Glaukos Corporation; NMRC Science Translational and Applied Research (STAR) award.