Key Takeaways
- The eyeValve reduced mean IOP by approximately 53% and maintained pressure within the physiological range for up to 9 months.
- No cases of hypotony, overdrainage, or sustained postoperative IOP elevation were reported, supporting the device's safety and pressure-regulating performance.
A novel miniaturized glaucoma drainage device, known as the eyeValve, demonstrated sustained intraocular pressure (IOP) control and a favorable safety profile in a first-in-human feasibility study involving 6 blind eyes with end-stage glaucoma and uncontrolled IOP.
In this prospective single-arm pilot study, investigators implanted the eyeValve into a partial-thickness intrascleral pocket and connected it to a distal silicone drainage plate (eyePlate) for orbital drainage. No mitomycin C was used. Patients were followed through 9 months after surgery.
Device implantation was successful in all eyes. The device was successfully implanted in all eyes and reduced mean IOP by approximately 53%, from 30.1 mmHg at baseline to 14.3 mmHg at 9 months, while maintaining IOP within the physiological range throughout follow-up.
No cases of hypotony, overdrainage, or sustained postoperative IOP elevation suggestive of bleb encapsulation were reported. Two eyes experienced transient iris-related tube occlusion. IOP control was maintained without glaucoma medication in 50% of eyes without tube obstruction during follow-up.
The investigators concluded that the eyeValve was feasible to implant, appeared safe, and provided sustained IOP regulation for up to 9 months without hypotony or hypertensive-phase behavior. They noted that larger studies are needed to further evaluate the device.
Reference
Rafiei S, Gerber JM, Bigler S, et al. First-in-human implantation of a self-adjustable glaucoma drainage device (eyeValve): safety and performance in blind eyes. Graefes Arch Clin Exp Ophthalmol. 2026;doi: 10.1007/s00417-026-07278-1. Epub ahead of print. PMID: 42213132.
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