Victor Koh1, Paul Chew1, Giacinto Triolo2, Kin Sheng Lim3, Keith Barton4. 1. Department of Ophthalmology, National University Hospital, Singapore, Republic of Singapore; Department of Ophthalmology, National University of Singapore, Singapore, Republic of Singapore. 2. Moorfields Eye Hospital, London, United Kingdom. 3. Department of Ophthalmology, St. Thomas' Hospital, London, United Kingdom. 4. Moorfields Eye Hospital, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: keith@keithbarton.co.uk.
Abstract
PURPOSE: To investigate efficacy 1 year after implantation of a novel glaucoma tube shunt, the PAUL Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore), in the treatment of eyes with refractory glaucoma. DESIGN: Clinical trial. PARTICIPANTS: Glaucoma patients who are recalcitrant to maximum tolerated medical therapy and require tube shunt surgery. METHODS: Interventional cohort study involving consecutive PGIs implanted at 6 international centers between December 1, 2017, and December 1, 2018. All the participants were followed up for 1 year after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined prospectively as intraocular pressure (IOP) of more than 21 mmHg or less than 20% reduction from the preoperative baseline on 2 consecutive visits, 3 months or more after surgery; persistent late hypotony, defined as IOP of less than 6 mmHg on 2 consecutive visits after 3 months; additional glaucoma surgery; loss of light perception vision; or removal of the implant for any reason. RESULTS: Of 82 patients enrolled, 74 (74 eyes) completed 12 months of follow-up. The mean age ± standard deviation at enrollment was 62.3±14.7 years, 73.0% were men, and 36.5% had secondary glaucoma. One year after surgery, 4 patients (5.4%) fulfilled the surgical criteria for failure, 68.9% (51/74 eyes) were deemed complete successes, and 93.2% (69/74 eyes) were considered qualified successes. Compared with the medicated preoperative IOP (23.1±8.2 mmHg), the postoperative IOPs at 6 and 12 months were 13.8±4.0 mmHg and 13.2±3.3 mmHg, respectively (P < 0.001). The mean number of IOP-lowering drugs used before surgery and after 12 months of follow-up were 3.3±0.9 and 0.3±0.6, respectively (P < 0.001). Significant postoperative complications included self-limiting shallow anterior chamber (n = 11; 14.9%), hypotony requiring intervention (n = 7; 9.5%), tube shunt occlusion (n = 5; 6.8%), tube exposure (n = 3; 4.1%), and endophthalmitis with resultant loss of vision (n = 1; 1.4%). CONCLUSIONS: The PGI demonstrated comparable efficacy with other currently available implants, with almost three quarters of the enrolled patients with refractory glaucoma achieving complete surgical success after 1 year of follow-up. Crown
PURPOSE: To investigate efficacy 1 year after implantation of a novel glaucoma tube shunt, the PAUL Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore), in the treatment of eyes with refractory glaucoma. DESIGN: Clinical trial. PARTICIPANTS: Glaucomapatients who are recalcitrant to maximum tolerated medical therapy and require tube shunt surgery. METHODS: Interventional cohort study involving consecutive PGIs implanted at 6 international centers between December 1, 2017, and December 1, 2018. All the participants were followed up for 1 year after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined prospectively as intraocular pressure (IOP) of more than 21 mmHg or less than 20% reduction from the preoperative baseline on 2 consecutive visits, 3 months or more after surgery; persistent late hypotony, defined as IOP of less than 6 mmHg on 2 consecutive visits after 3 months; additional glaucoma surgery; loss of light perception vision; or removal of the implant for any reason. RESULTS: Of 82 patients enrolled, 74 (74 eyes) completed 12 months of follow-up. The mean age ± standard deviation at enrollment was 62.3±14.7 years, 73.0% were men, and 36.5% had secondary glaucoma. One year after surgery, 4 patients (5.4%) fulfilled the surgical criteria for failure, 68.9% (51/74 eyes) were deemed complete successes, and 93.2% (69/74 eyes) were considered qualified successes. Compared with the medicated preoperative IOP (23.1±8.2 mmHg), the postoperative IOPs at 6 and 12 months were 13.8±4.0 mmHg and 13.2±3.3 mmHg, respectively (P < 0.001). The mean number of IOP-lowering drugs used before surgery and after 12 months of follow-up were 3.3±0.9 and 0.3±0.6, respectively (P < 0.001). Significant postoperative complications included self-limiting shallow anterior chamber (n = 11; 14.9%), hypotony requiring intervention (n = 7; 9.5%), tube shunt occlusion (n = 5; 6.8%), tube exposure (n = 3; 4.1%), and endophthalmitis with resultant loss of vision (n = 1; 1.4%). CONCLUSIONS: The PGI demonstrated comparable efficacy with other currently available implants, with almost three quarters of the enrolled patients with refractory glaucoma achieving complete surgical success after 1 year of follow-up. Crown
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