Atia Vision has unveiled three-year first-in-human data for its investigational OmniVu Lens System, reporting sustained refractive stability and a continuous range of vision through 36 months after implantation. The results, presented at the 2026 ASCRS Annual Meeting by the Medical Director of the Cleveland Eye Clinic, William F. Wiley, were awarded Best Paper of Session, and add to growing interest in accommodating and modular approaches to premium cataract surgery.
The prospective, multicenter, open-label study included 19 patients and 29 eyes, with both monocular and binocular implants. According to the company, mean manifest refraction spherical equivalent remained within ±0.50 D throughout the three-year follow-up, while refractive cylinder also remained stable over time.
Visual acuity outcomes were similarly strong. At 36 months, mean binocular uncorrected distance visual acuity was reported as -0.11 logMAR, equivalent to approximately 20/16, with best-corrected distance acuity of -0.17 logMAR, or about 20/12. Mean binocular uncorrected intermediate acuity was -0.05 logMAR (20/20), while mean uncorrected near acuity reached 0.06 logMAR, roughly 20/25. Defocus testing showed 20/32 or better vision across around 5.0 D of continuous defocus, suggesting a broad functional range from distance through near.
Safety findings were also notable. Across all implanted eyes and all follow-up visits, the company reported only one YAG capsulotomy, with no lens exchanges and no refractive enhancements required. Early contrast sensitivity data from a six-month sub-study were described as comparable to published monofocal IOL benchmarks under mesopic conditions – an important point for a presbyopia-correcting platform, where dysphotopsia and contrast trade-offs remain central concerns.
The OmniVu system uses a two-part modular design: a fluid-filled, shape-changing base intended to respond to the eye’s natural accommodative mechanism, paired with a front optic designed to deliver the required refractive correction. Atia says the capsularbag-filling design is intended to support more stable effective lens position and reduce posterior capsule opacification.
President and CEO of Atia Vision, Mariam Maghribi, commented that Atia has ““challenged long-held assumptions about lens design, and the durability of these outcomes validates that approach. Our team is energized by this milestone, and we remain focused on delivering a lens that gives surgeons the confidence and patients the quality of vision they deserve.”
While the device currently remains investigational and is not approved for sale in any market, the OmniVu Lens System has received FDA IDE approval to begin a US feasibility study, setting the stage for the next phase of clinical evaluation.
For cataract surgeons watching the evolution of premium IOL technology, the 36-month data offer an early but intriguing signal that shape-changing, modular designs may yet carve out a meaningful role in the future presbyopia-correcting landscape.
Source: BusinessWire.