Efficacy And Safety Of Paul Implant In Refractive Glaucoma: A Long-Term Study

To determine the long term efficacy and safety of Paul tube implant in refractory glaucoma.

Glaucoma patients from all ages who underwent Paul implant were recruited from two different settings, a tertiary referral university hospital, and one of the reputable private sector eye centres between June 1st., 2022 and October last, 2024. Patients were followed up for a minimum of 12 with an average follow-up duration of 10.4 (6.2), [3 – 26] months. 

Surgical intervention included using ripcord (6-0 prolyne) inserted inside the tube at the time of surgery. Surgical quadrant was left to the surgeon preference: superior-temporal position was chosen in the majority of cases 53 (80.3%), while it was inferior-temporal in 11 (16.7%) of the cases. A 0.2 Mitomycin was used in 61 (98.4%) of the cases. The patch graft type was Tutoplast in all (100%) of the cases. Both demographic and clinical glaucoma indices were collected pre- and post-operative, then followed up to a minimum of 12 months. Reduction in IOP, and success rates were calculated, and postoperative complications were assessed.

The IOP was significantly reduced from a preoperative average of 28.7 (10.7) mmHg to 15.7 (8.1) mmHg postoperatively, p<0.0001. At the last follow-up assessment visit the IOP reached up to 13.7 (5.7) mmHg, p=0.005. The average number of anti-glaucoma medications was significantly reduced from 3.3 (0.9) preoperatively, to 0.2 (0.6) postoperatively, p<0.0001, while at the last follow-up assessment, it was stable at 0.2 (0.6). The complete success rate was 53 (81.5%), qualified success was 7 (10.8%), overall success was 60 (92.3%). Main complications were AMD 3 (4.5%), Choroidal after suture removal: 1 (1.5), Conjunctival Dehiscence: 2 (3.0), and Hyphemia: 3 (4.5) with an overall complication rate of 9 (13.6%).

Paul tube has comparable efficacy and safety profile to other equivalent glaucoma devices, the implant safety is quite valid for both adult and congenital refractive glaucoma cases.