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.