A prospective randomised comparison of two different stenting sutures when using the Baerveldt 101–350 aqueous shunt – Lab transition to clinical process

Abstract Purpose The Baerveldt glaucoma drainage implant (BGI 101–350) is one of the most effective treatment options for managing refractory glaucoma. To mitigate early hypotony in non‐valved implants, intraluminal occluding sutures (IOSs) are commonly used. This study compares the swelling behavior of two widely used IOSs: 3–0 nylon (Supramid Extra) and 3–0 polypropylene (Prolene). Long‐term clinical outcomes associated with each suture material are also evaluated. Methods A prospective randomised interventional study was conducted involving 94 patients undergoing BGI 101–350 implantation, divided into two groups: Supramid ( n  = 48) and Prolene ( n  = 46). An experimental swelling model using confocal microscopy and ImageJ software quantified the hygroscopic behavior of each suture material by determining the intraluminal gaps area before and after wetting. Postoperative intraocular pressure (IOP), medication use and removal timing were analyzed over 60 months using independent‐samples t ‐tests, while categorical variables, including hypotony rates and the need for suture adjustment, were compared using χ 2 tests. Results The experimental model demonstrated ~60% swelling in Supramid vs. ~3% in Prolene IOS. Clinically, both groups achieved comparable IOP control at 6, 12 and 60 months (mean IOP at 60 months: Supramid 11 ± 1.75 mmHg, Prolene 11 ± 1.37 mmHg; p  > 0.05). The Prolene group required markedly fewer postoperative interventions: no suture adjustments compared with 10 in the Supramid group ( p  = 0.001), and suture removal occurred significantly later (mean 8.9 vs. 4.96 months; p  < 0.001). Transient hypotony following suture removal occurred in 6.25% of Supramid cases and in none with Prolene. Conclusions 3–0 Prolene offers better predictability and repeatability, earlier IOP control, delayed and safer suture removal and reduced need for early interventions while maintaining equivalent long‐term IOP control.