Three-Year Efficacy and Safety of the PAUL Glaucoma Implant
DOI:
https://doi.org/10.48560/rspo.33256Keywords:
Filtering Surgery, Glaucoma Drainage Implants, Glaucoma/surgery, Intraocular PressureAbstract
INTRODUCTION: PAUL glaucoma implant is a non-valved posterior drainage device with a smaller lumen tube compared with classical alternatives. This study aimed to determine the 3-year efficacy and safety of the PAUL glaucoma implant.
METHODS: Retrospective cohort study. Consecutive patients implanted with a PAUL Glaucoma Implant between December 2018 and August 2020, with a minimum follow-up period of 36 months, were included. The clinical data were acquired from the patients' records. The primary outcome was the reduction in intraocular pressure (IOP) at 36 months, with surgical success defined as ≤18 mmHg and >5 mmHg plus ≥30% drop in IOP from baseline. Failure was defined as not reaching the criteria for success for two consecutive observations after 3 months of follow-up, need for surgical intervention, or significant vision loss. Safety outcomes were also analyzed. A standardized surgical protocol was followed in all cases, which included augmentation with mitomycin C (0.4 mg/mL) and tube ligation with a polyglactin suture.
RESULTS: A total of 27 eyes from 23 patients met the inclusion criteria. Both adult and pediatric forms of glaucoma were included. The mean age at the time of surgery was 36.1±27.5 (5 months - 76 years) years. Two-thirds (n=18) had a history of previous glaucoma surgery. IOP showed a statistically significant reduction at month 36 compared to baseline IOP [preoperative IOP: 30.4±10.5 vs postoperative M36 IOP: 13.7±4.7 mmHg; p<0.001]. Surgical success was achieved in 66.6% of cases at 36 months. There was also a statistically significant reduction in preoperative medications from 2.8±1.4 to 1.0±0.9 (p<0.001). During the follow-up period, persistent hypotony requiring surgical intervention was observed in 1 patient. Revision surgery was necessary in 5 patients (18.5%).
CONCLUSION: The PAUL glaucoma implant is a novel posterior drainage device that shows efficacy and acceptable safety in the long-term treatment of refractory glaucoma.
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