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PURPOSE: To determine two-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 1 May 2017 and 30 March 2021. MAIN OUTCOME MEASURES: 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 unmedicated IOP ≤18▒mmHg or ≥6▒mmHg 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. 30 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 to mean medicated pre-operative IOP (19.8±6.3▒mmHg), post-operative IOP at 24 months was 13.9±3.7 (P<0.01). Mean number of medications decreased from 3.2±0.8 pre-operatively 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 post-surgery in patients with advanced glaucoma.
Department of Ophthalmology, National University Health System Yong Loo Lin School of Medicine, National University of Singapore.
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