Six-Month Clinical Outcomes Of A New Laser Titratable Aqueous Shunt Feasibility Trial
Published 2025 - 43rd Congress of the ESCRS
Reference: PO667 | Type: Free paper | DOI: 10.82333/t35b-cx68
Authors: Alessandra Curci* 1 , Alice Carbucicchio 2 , Eleonora Ferioli 2 , Paolo Nucci 2 , Edoardo Villani 3
1Eye Clinic San Giuseppe Hospital,Milan,Italy, 2University of Milan,Milan,Italy, 3Department of Clinical Science and Community Health,University of Milan,Milan,Italy
Purpose
Assess the six-month clinical safety, procedural success, and efficacy of a laser-titratable sub-conjunctival aqueous shunt, with modifiable postoperative outflow resistance.
Setting
Ongoing, single-arm, multi-center feasibility clinical trial (NCT05885022), conducted by glaucoma-trained physicians at four private clinics in Mexico, Panama, and India. 31 eyes with open-angle glaucoma were implanted with the Calibreye System (Myra Vision, Campbell, CA) across these sites, with evaluation of intraocular pressure (IOP) and IOP-lowering medication usage and adverse events.
Methods
Calibreye aqueous shunt implantation with Mitomycin- C and postoperative laser outflow titration were assessed. Aqueous humor drains to the equatorial subconjunctival space through the shunt via three microfluidic channels. Two channels are controlled by nitinol valves that can be repeatedly opened or closed using a slit lamp mounted green laser. After implantation, the investigators titrated device resistance by opening and closing the valves to control IOP. Days 1 and 3, Weeks 1, 2, and 3, and Month 1, 3 and 6 postoperative study visits were required. At each visit, adverse events, medication use, and IOP were evaluated.
Results
Baseline IOP was 22.7±4.5 mmHg (mean ±SD) on 3.2±1.2 medications with a visual field mean deviation of -19.0±10.3 dB. There were no complications during implantation. Laser titration was performed in all 31 eyes without procedural related AEs. One case of persistent hypotony maculopathy required explantation. Transient mild AEs occurred in 19 eyes, mostly early and resolving conservatively. No needlings were performed. At 6 months, the IOP decreased by 36.4% from baseline to 13.9±4.5 mmHg (mean±SD) on 0.4±0.9 medications with 74.2% medication free. 8 eyes reached target IOP without full channel activation.
Conclusions
The titratable Calibreye aqueous shunt demonstrated procedural success, a reduction in IOP and IOP lowering medication burden with a comparable safety profile in this feasibility trial. The Calibreye shunt may offer a novel opportunity to, not only lower postoperative IOP levels after glaucoma surgery, but also to adjust them upwards if deemed too low.