Iqbal K Ahmed, MD, director of the Alan S. Crandall Glaucoma Innovation Center, Moran Eye Center, University of Utah, Salt Lake City, and colleagues report that this novel intra-ab water-draining suprachoroidal bioimplant is surgically feasible and safe , and has a “powerful” intraocular pressure (IOP) lowering effect.
The device, a scleral biotissue, created by Sean Ianchulev, MD, MPH, of New York Eye and Ear Hospital and the Icahn School of Medicine at Mount Sinai in New York, is a compliant implant material, a soft sclera that conforms to the wall biotissue Structurally reinforced Cyclodialysis crack openings.
The device contains no hardware, i.e. no plastic, metal or rigid, foreign bodies, and no rebound motion; it features enhanced post-deployment fixed tissue hydration and in situ dilation of the fissure.
The researchers noted that biological tissue is 10 times more permeable than the cornea.
They investigated the clinical manifestations of this bioscaffold in reducing intraocular pressure in open-angle glaucoma (OAG).
All surgeries were performed at 1 center. They describe that in patients undergoing concomitant cataract surgery and enhanced intra-abdominal ciliary dialysis with this microcircularized scleral donor tissue bioscaffold, the key outcomes were adverse events at 12 months postoperatively, ability to lower intraocular pressure, and Use of antiglaucoma drugs.
Stent Implantation Results
Ten consecutive OAG patients with vision-related cataracts (mean age 74.1 years) were included in the study in one eye each. Mean preoperative baseline IOP was 24.2 ± 6.9 mmHg; patients used an average of 1.3 ± 0.8 ocular hypotensive medications. All eyes were successfully implanted with stents without vision-related complications. No eye lost more than 2 lines of best corrected visual acuity.
“At 12 months post-implantation, 80 percent of eyes had a 20 percent or more reduction in intraocular pressure,” the researchers reported.
The mean postoperative intraocular pressure was 14.6 ± 3.2 mmHg, which represented an average 40% reduction in intraocular pressure. Along with this reduction, the use of ocular antiglaucoma medications dropped by 62%.
The conclusion of the first-in-human experience of this water-draining suprachoroidal bioimplant is that the implant demonstrates surgical feasibility, safety, and a strong IOP-lowering effect.
“The device created a durable conduit for the suprachoroidal outflow tract. The allograft bioscaffold was well tolerated, with no intraocular adverse events or inflammation during standard post-ultrasound treatment. The allograft appeared to have no tissue reaction. The bioscaffold was stable in the ciliary fissure as assessed by clinical gonioscopy, with no postoperative migration or corneal contact, likely due to the lack of rigid metal or polymer materials in first-generation MIGS implants,” the study said. personnel concluded.