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.

Clinical outcomes of the PAUL® glaucoma implant: One‐year results

“…15 Tan et al reported ocular hypotony in 10 out of 45 eyes with four needing an additional intervention due to its persistence. 16 Study results from Vallabh et al and José et al are in concordance to our findings and underscore the low complication rate of the PGI, especially with regard to postoperative hypotony. In comparison to Tan et al, we found a lower postoperative hypotony rate.…”

“…Their results are comparable to our data albeit their study including two-year results. 16 Our results confirm that the PGI leads to a significant reduction of IOP and considerably lowers the number of antiglaucomatous eye drops at a low complication rate.…”

“…They demonstrated that the IOP reduction was also sustained into the second year after surgery: the mean IOP was reduced from 19.8 mmHg preoperatively to 13.9 mmHg at 2 years. 16 We assume that a similar IOP profile would be maintained at 2 years for our cohort (Table 3).…”

Implante de Paul vs. Baerveldt en glaucoma refractario

“…Ambos implantes permiten un control efectivo de la PIO en nuestro seguimiento a tres meses. En la literatura se describe un porcentaje de éxito del 93.2% a un año de seguimiento con PGI y una PIO promedio a los tres meses de 14.54 mmHg, lo cual concuerda con nuestros resultados de 13.8 mmHg 9,10 . En nuestros casos no hubo diferencias en el número de gotas hipotensoras postoperatorias entre ambos grupos, ni tampoco al comparar las gotas preoperatorias y postoperatorias.…”

Uveitis and glaucoma: a look at present day surgical options

“…Postoperative complications such as the presence of a shallow anterior chamber was seen in 22% of patients but most of these was self-limiting, hypotony requiring further intervention was seen in 9% of patients and tube occlusion was also seen in 9% of patients. However, literature evaluating its efficacy in uveitic glaucoma eyes is limited at present [30 ▪ ].…”