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Long-term outcomes of the Paul glaucoma implant in a paediatric population: A retrospective cohort study
Clarissa Ern Hui Fang1, Nyaish Mansoor2, Kenneth Yau2
1Manchester Royal Eye Hospital, Manchester University NHS Foundation Trust, Manchester, UK. fangclarissa@gmail.com.
Insights
The Paul Glaucoma Implant (PGI) effectively lowers intraocular pressure and reduces medication needs in pediatric glaucoma patients. This study confirms PGI as a safe and viable long-term surgical solution for refractory cases.
Area of Science:
- Ophthalmology
- Surgical Innovation
- Pediatric Glaucoma Management
Background:
- Refractory pediatric glaucoma presents significant long-term management challenges.
- Evaluating the efficacy and safety of novel surgical interventions is crucial for this population.
Purpose of the Study:
- To assess the long-term effectiveness and safety of the Paul Glaucoma Implant (PGI) in pediatric patients.
- To analyze intraocular pressure (IOP) control, medication reduction, and complication rates following PGI implantation.
Main Methods:
- Retrospective review of 113 eyes from 83 pediatric patients (age 4 months–18 years) who received PGI.
- Data collected included preoperative and postoperative IOP, medication usage, complications, and surgical success rates over a 5-year period.
Main Results:
- Significant IOP reduction was observed post-PGI implantation, sustained up to 60 months (p < 0.001).
- Mean medication use decreased from 3.8 to 0.7-1.0 postoperatively, with 59% of eyes becoming medication-free.
- Complete and qualified success rates were 49.3% and 81.4% respectively at 5 years. Major complications included tube exposure and hypotony (2.7% each).
Conclusions:
- The Paul Glaucoma Implant demonstrates sustained efficacy in reducing IOP and medication burden in pediatric glaucoma.
- PGI offers an acceptable safety profile and represents an effective long-term surgical option for refractory pediatric glaucoma.
Background:
To evaluate the long-term efficacy and safety of the Paul Glaucoma Implant (PGI) in a paediatric cohort.
Methods:
A retrospective review of 113 eyes from 83 paediatric patients (age range 4 months to 18 years, mean 9 ± 5 years) who underwent PGI implantation between June 2019 and April 2024. Intraocular pressure(IOP), medications, complications, and surgical success rates were assessed.
Results:
The mean preoperative IOP was 27.2 ± 6.2 mmHg. Postoperatively, IOP significantly decreased at all time points (p < 0.001), measuring 14.0 at 12 months, 13.7 at 24 months, 12.5 at 36 months, 12.5 at 48 months, and 13.7 at 60 months. The mean number of preoperative medications was 3.8 ± 0.8. Postoperatively, they were 0.9 at 12, 18, and 24 months, 0.7 at 36 months, 1.0 at 48 months, and 0.7 at 60 months (p < 0.001). 59% of eyes were medication-free at final follow-up. Thirty-nine eyes (35%) underwent Prolene stent removal (mean 9.7 months post-op), resulting in further IOP reduction (14.3 mmHg) and medication (0.8). Complete success rates (IOP ≤ 21 mmHg without medication) were 67.2% at 1 year, 58.2% at 2 years, 51.9% at 3 years, 50.1% at 4 years, and 49.3% at 5 years. Qualified success rates (IOP ≤ 21 mmHg with or without medication) were 91.2%, 88.5%, 85.8%, 85.0%, and 81.4% at the same intervals. 31(27.4%) eyes required further surgical intervention, most commonly for IOP control(21.2%). Major complications included tube exposure(2.7%) and hypotony(2.7%).
Conclusion:
PGI demonstrates sustained IOP reduction, reduced medication burden, and an acceptable safety profile in refractory paediatric glaucoma. It represents an effective long-term surgical option for this challenging cohort.
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