Could Glaucoma Surgery Become a 10-Minute Office Procedure? First Human Results From OBi Core

This audio article is from VisualFieldTest.com.Read the full article here: https://visualfieldtest.com/en/could-glaucoma-surgery-become-a-10-minute-office-procedure-first-human-results-from-obi-coreTest your visual field online: https://visualfieldtest.comSupport the show so new episodes keep coming: https://www.buzzsprout.com/2563091/supportExcerpt:Could Glaucoma Surgery Become a 10-Minute Office Procedure? First Human Results From OBi Core Short answer: OBi Core is one of the more interesting new glaucoma procedures because it attempts to combine the pressure-lowering power of filtration surgery with the convenience of an office-based slit-lamp procedure. But the current evidence is still extremely early. The publicly reported human experience consists of a small first-in-human series of approximately 10 eyes with detailed results, followed by a company update describing 11 treated eyes. Follow-up is short, patient-level data are not publicly available, and approximately 30% of eyes required reintervention in the initial detailed report. () The technology is therefore promising, but not yet proven to replace trabeculectomy. Its most important scientific question is not whether it can lower pressure initially. The early data suggest that it can. The difficult question is whether the subconjunctival bleb can remain functional for years without recreating the fibrosis, needling, medication, and monitoring burden of conventional filtering surgery. The Bottom Line OBi Core is not a conventional angle-based minimally invasive glaucoma surgery. It creates a direct pathway from the anterior chamber to a subconjunctival or sub-Tenon filtration space. The device appears to use a 27-gauge, 6-millimeter punch needle to create an oblique scleral microchannel approximately 150 ± 50 micrometers in diameter. () It does create a subconjunctival filtration bleb, meaning it shares the central biological weakness of trabeculectomy, XEN Gel Stent, and PreserFlo MicroShunt: wound healing and fibrosis can eventually reduce flow. The detailed first-in-human report involved 10 eyes followed for up to approximately 6 weeks. Mean intraocular pressure fell from 30.1 to 10.2 millimeters of mercury, a calculated absolute reduction of 19.9 millimeters of mercury, or approximately 66%. Mean glaucoma medications fell from 2.2 to 0.8, an absolute reduction of 1.4 medications, or approximately 64%. Seventy percent of eyes reportedly achieved complete success under the study definition, and approximately 78% were medication-free, although the denominators and patient-level data were not fully disclosed. Thirty percent required reintervention, including repeat OBi Core procedures or other filtration procedures. The reasons for those interventions have not been publicly separated into fibrosis, obstruction, inadequate flow, or surgical learning-curve effects. () A September 2026 company update described 11 treated eyes, including mild, moderate, and advanced glaucoma, with early pressures in the single digits to low teens and no reported device- or procedure-related adverse events. No detailed aggregate results from the eleventh eye were provided. () The “10-minute” description is not yet supported by a published procedural-time dataset. The channel-creation step may take seconds, but the full visit—including preparation, anesthesia, mitomycin C, intraocular pressure management, and postoperative testing—has not been formally reported. What Is OBi Core? Manufacturer and development status OBi Core is being developed by Hexiris Ophthalmics, a Canadian company based in Dieppe, New Brunswick. Hexiris describes OBi Core as a device for minimally invasive bleb surgery, usable either at the slit lamp or in an operating room. () The clinical-trial registry uses the more generic name Hexiris Microinvasive Scleral Trephine, or MIST. The registered first-in-human study is a Canadian, multicenter, open-label, single-arm study intended to enroll 25 adults with primary open-angle glaucoma. The first five cases are planned in an operating room, after which the safety monitor may allow the remaining procedures to move to an aseptic slit-lamp setting. () Hexiris states that OBi Core has a Health Canada medical device license and is FDA registered. FDA registration does not by itself mean that a device has received United States clearance or approval for routine commercial use. The company has indicated that commercial introduction in selected markets may begin in early 2027, subject to regulatory requirements. () Device design The publicly described OBi Core system consists of: A handpiece A 27-gauge punch needle A needle approximately 6 millimeters long An actuator that advances the cutting element A scleral punch that removes a small core of tissue A resulting oblique microchannel approximately 150 ± 50 micrometers in diameter The device is not described as leaving a permanent implant in place. Instead, it creates a tissue channel. A related Hexiris patent describes the concept as a drainage pathway created by removing a small tissue core, with no artificial tube left inside that channel. () That is an important distinction: XEN and PreserFlo leave a permanent implant. OBi Core appears to create a micro-sclerostomy without leaving a permanent tube. A separate Hexiris product called OBi Shunt is being developed as an implantable device, but it is a different product and should not be confused with OBi Core. () What Drainage Pathway Does It Create? The publicly described pathway is: > Anterior chamber → scleral microtunnel → posterior subconjunctival or sub-Tenon space → absorption through surrounding tissues and episcleral vessels The approach is ab externo, meaning the surgeon approaches the eye from the outside. The device is placed through the conjunctiva and sclera, with the punch directed into the anterior chamber. The described target location is generally the superior or superotemporal sclera, approximately 1.0 to 1.5 millimeters behind the limbus. () The procedure is therefore a form of penetrating filtration surgery, although it is much smaller than a traditional trabeculectomy. Is a bleb formed? Yes. OBi Core is a bleb-forming procedure. Aqueous humor is intended to collect in a posterior subconjunctival or sub-Tenon space, creating a filtration reservoir. This reservoir is commonly called a bleb. The fluid is then absorbed through surrounding tissue and blood vessels. () This means OBi Core does not completely escape the biological problems of conventional glaucoma filtration surgery. It may reduce tissue trauma, but it still depends on: A functioning drainage channel A healthy subconjunctival space Controlled wound healing A bleb that remains open rather than becoming scarred or encapsulated How Is the Procedure Performed? The exact first-in-human operative protocol has not been published in a peer-reviewed clinical paper. However, the publicly described technique includes the following elements. Publicly described procedural sequence The eye is anesthetized with topical anesthesia. The procedure is performed at the slit lamp in an aseptic office environment. A small subconjunctival or sub-Tenon pocket is created or accessed. A bolus of cohesive ophthalmic viscoelastic is placed in the anterior chamber to reduce excessive early flow. The OBi Core device is positioned on the superior or superotemporal sclera. The actuator advances the punch needle through the conjunctiva and sclera into the anterior chamber. A small scleral tissue core is removed, creating the microchannel. Mitomycin C is injected into the subconjunctival pocket. Pilocarpine may be used to pull the iris away from the internal opening. The surgeon performs a Seidel test to look for leakage. Postoperative antibiotics and steroids are prescribed. The bleb and intraocular pressure are monitored closely. The described technique includes mitomycin C at 0.4 milligrams per milliliter, equivalent to approximately 0.04%. The registered MIST trial specifies a subconjunctival mitomycin C concentration of 0.02% to 0.04%. () Is it performed entirely at a slit lamp? The intended office-based version appears to be performed at the slit lamp, without major capital equipment. However: The first five cases in the registered study are planned in an operating room. The procedure can also be performed in an operating room. The surgeon must still enter the anterior chamber. The eye must be prepared with sterile or aseptic technique. The practice must be capable of recognizing and managing hypotony, bleeding, iris obstruction, wound leakage, and other intraocular problems. Thus, “office-based” does not mean “noninvasive” or “risk-free.” How long does it take? The available clinical sources call the procedure rapid, and the underlying patent describes the tissue-channel creation step as occurring in the order of seconds. However, no reliable published study currently reports the total procedure time from patient preparation to discharge. () The most accurate conclusion is: > OBi Core may be a short office procedure, but the public evidence does not yet establish that the complete treatment reliably takes 10 minutes. The full time would include topical anesthesia, sterile preparation, conjunctival manipulation, anterior chamber viscoelastic, mitomycin C injection, pressure testing, and postoperative instructions. Reconstructing the First Human Results Detailed first-in-human report The most detailed publicly available report came from a presentation at the 2026 American Society of Cataract and RefractiveSupport the show