A recent study reported on the safety and efficacy of bio-interventional cyclodialysis with scleral allograft reinforcement in 243 eyes with open-angle glaucoma. This procedure aimed to enhance uveoscleral outflow by reinforcing the internal filtration channel with acellular allograft biotissue, creating a durable, non-resorbable conduit for fluid outflow.
“The scleral allograft has demonstrated excellent safety as an inert biocompatible and non-biodegradable material that can reinforce the ocular surface and the integrity of the scleral interface/wall, as well as protect the ocular tissues from the erosive effects of implantable hardware, such as glaucoma drainage devices,” the researchers wrote in their article in the Journal of Clinical Medicine. Their clinical series is the largest to date of intraocular allegeneic biotissue implantation.
At 12 months post-surgery, the mean intraocular pressure (IOP) decreased 27.1% from baseline, and 78.6% of treated eyes achieved IOP ≤18 mmHg without requiring additional medications postoperatively.
“It is encouraging that the incidence of postoperative inflammation and iritis were indistinctly similar to the standard-of-care phaco procedures,” the investigators wrote. These evaluations were completed with slit lamp bio-microscopy, which is a sensitive and quantifiable approach to evaluate inflammatory response at the cellular level. The researchers also noted evidence of early post-implantation stability without apparent postoperative migration.
Because their follow-up period went to only 30 days post-op, they encouraged long-term studies on further clinical benefits, efficacy, and durability, as well as investigations on “whether scleral allograft reinforcement can address early closure of the cleft in some patients and maintain long-term patency of the uveoscleral outflow channel.” Still, the real-world data provided support for the minimally invasive procedure.
A full list of author disclosures can be found in the published research.