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Treatment Outcomes Using the PAUL Glaucoma Implant to Control Intraocular Pressure in Eyes with Refractory Glaucoma

PurposeTo investigate efficacy one year after implantation of a novel glaucoma tube shunt, the PAUL® Glaucoma Implant (PGI) in the treatment of eyes with refractory glaucomaDesignClinical trialParticipantsGlaucoma patients who are recalcitrant to maximum tolerated medical therapy and require tube shunt surgeryMethodsInterventional cohort study involving consecutive PGI’s implanted at 6 international centers between 1 December 2017 and 1 December 2018. All the participants were followed-up for one year after surgery and clinical data were collected using a standardized data-collection form.Main Outcome MeasuresThe primary outcome measure was failure, defined prospectively as intraocular pressure (IOP) > 21mmHg or < 20% reduction from the pre-operative baseline on 2 consecutive visits, 3 months or more after surgery, persistent late hypotony, defined as IOP < 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.ResultsOf 82 patients enrolled, 74 (74 eyes) completed 12 months of follow-up. The age at enrollment was 62.3 ± 14.7 (mean ± SD) years, 73.0% male and 37.8% had secondary glaucoma. One year after surgery, 4 (5.4%) patients fulfilled the surgical criteria for failure, 68.9% (51/74 eyes) were deemed complete successes and 93.2% (69/74 eyes) qualified successes. Compared with the medicated pre-operative IOP (23.1 ± 8.2 mmHg), the post-operative IOP at 6 and 12 months were 13.8 ± 4.0 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 post-operative 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%).ConclusionThe PGI demonstrated comparable efficacy to other currently available implants with almost three-quarters of the enrolled patients with refractory glaucoma achieving complete surgical success after one year of follow-up.

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