Two-Year Outcomes of the Paul Glaucoma Implant for Treatment of Glaucoma

Abstract

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.

FIGURE 1

Picture of the Paul Glaucoma Implant (Advanced Ophthalmic Innovations, Singapore) with relevant dimensions.

FIGURE 2

Kaplan-Meier survival curve for eyes implanted with the PAUL Glaucoma Implant (Advanced Ophthalmic Innovations, Singapore) over 2 years. Time to failure was defined as time from implantation to the first of 2 consecutive study visits after 3 months in which IOP <5 mm Hg, or >18 mm Hg, loss of light perception or to reoperation for glaucoma or implant related complications.

FIGURE 3

Line graph showing intraocular (IOP) trend before and after surgery up to 2 years, compared to both the highest preoperative IOP and preoperative medicated IOPs. The error bars indicate 95% confidence limits.

FIGURE 4

Line graph showing the number of intraocular pressure (IOP) lowering medications used before and after surgery. Error bars indicate 95% confidence limits.