Surgical Outcomes, Ocular Safety and Tolerability of Bio-Interventional Cyclodialysis with Allograft Scleral Reinforcement: Clinical Experience of More than 240 Cases.

ABSTRACT

Background: To report the surgical safety of reinforced bio-interventional cyclodialysis with scleral allograft reinforcement. Methods: This was a consecutive case series of 243 eyes with open-angle glaucoma who underwent a bio-scaffolded cyclodialysis (BSC) procedure for uveoscleral outflow enhancement using allogeneic bio-spacers to maintain patency of the internal filtration conduit. Results: 79% of the eyes underwent concomitant phacoemulsification cataract surgery prior to BSC intervention, while the remaining eyes underwent stand-alone BSC surgery. All patients had a postoperative surgical safety period of at least 30 days. There were no sight-threatening or serious ocular adverse events. There was one case of prolonged iritis beyond 30 days, which resolved with topical treatment. Two cases (0.8%) of intraoperative and five (2%) of postoperative non-sight-threatening hyphema were without clinical sequelae, which resolved with conservative management. There were 11 cases of IOP elevation and one case of numeric hypotony without maculopathy, which resolved within the study period. The rate of secondary surgical intervention for IOP control was low, and overall, IOP for the cohort improved in the postoperative period, with 78.6% of eyes achieving IOP ≤ 18 mmHg without an increase in medications. Conclusions: Allogeneic biotissue for cyclodialysis intervention demonstrates a biocompatible ocular profile as an implantable material for internal scleral reinforcement during uveoscleral outflow enhancement surgery.