Atia Vision, Inc., a Shifamed portfolio company, announced in a press release positive 36-month results from its first-in-human clinical study of the Atia Vision OmniVu Lens System, a modular shape-changing intraocular lens (IOL) designed to restore a continuous, dynamic range of vision following cataract surgery.

The data was presented in the paper, "Durability of Visual and Refractive Outcomes with a Modular Shape-Changing IOL" by William F. Wiley, MD, medical director of the Cleveland Eye Clinic, at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting, and was awarded Best Paper of Session.

According to Dr. Wiley, the results demonstrate sustained visual and refractive outcomes through 36 months post-implantation, with a favorable and stable safety profile. 

The prospective, multicenter, open-label study enrolled 19 subjects (29 eyes), including 10 binocular and 9 monocular implants. Key findings presented by Dr. Wiley from the study at 36 months noted stable refractive outcomes; mean manifest refraction spherical equivalent remained within ±0.50 D throughout 36 months of followup. Refractive cylinder also demonstrated stability over time.

In his presentation, Dr. Wiley also noted strong binocular visual acuity. At 36 months, mean binocular uncorrected distance visual acuity was -0.11 logMAR (20/16) and mean best-corrected distance visual acuity was -0.17 logMAR (20/12). Mean binocular uncorrected intermediate visual acuity was -0.05 logMAR (20/20) and mean binocular uncorrected near visual acuity was 0.06 logMAR (20/25, J1).

Regarding continuous range of focus, Dr. Wiley explained that binocular defocus curve testing demonstrated 20/32 or better vision over approximately 5.0 D of continuous defocus. He also pointed out that, across all eyes and all study visits, only 1 YAG capsulotomy procedure was performed, and that no lens exchanges or refractive enhancements were required.

Finally, Dr. Wiley noted that early contrast sensitivity results from a sub-study at 6 months showed monocular mesopic performance comparable to published monofocal IOL literature, a notable finding for a presbyopia-correcting lens delivering full range of vision, he said.

“What excites me from a practice management standpoint is the potential to reduce complexity," said Dr. Wiley. "If we can deliver a continuous range of vision with this level of stability and low intervention rates, it allows surgeons to spend less time managing trade-offs and more time focusing on outcomes, which ultimately improves both efficiency and scalability.”

According to Atia Vision, the OmniVu Lens System features a 2-component modular design: a fluid-filled, shape-changing base intended to respond to the eye’s natural accommodative mechanism to provide dynamic focusing, and a front optic that aims to reliably meet each patient’s refractive prescription. In addition, the capsular bag-filling design is engineered to preserve a more natural physiologic shape of the eye, which is intended to promote stable lens position and minimize posterior capsule opacification formation, the company said.

The Atia Vision OmniVu Lens System has received Investigational Device Exemption approval from the US Food and Drug Administration (FDA) to begin a US feasibility clinical study.