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

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.