Modular, shape-changing IOL for presbyopia improves vision at 36 months, study finds

Atia Vision has presented positive 36-month results from its first-in-human study of the Atia Vision OmniVu Lens System.¹

Presented at the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting by William Wiley, MD, medical director of the Cleveland Eye Clinic, these data reflect the modular shape-changing IOL’s capacity to restore a continuous and dynamic range of vision.¹

“Surgeons have long had to accept trade-offs with presbyopia-correcting lenses. Unpredictable effective lens position, routine YAG [yttrium-aluminum-garnet] capsulotomy, and compromised visual quality have simply been the cost of offering patients a range of vision,” Wiley said in a statement. “These 36-month data tell a very different story. Continuous focus from far to near, stable lens position, and remarkably low YAG rates sustained over 3 years is exactly what we need to see.”¹

Atia Vision received investigational device exemption clearance from the FDA in May 2025, allowing the company to proceed with a US clinical trial of the OmniVu Lens System. Prior to this clearance, the system had been evaluated internationally via first-in-human trials and feasibility clinical trials.²

The present study was a prospective, multicenter, open-label study enrolling 10 patients (14 eyes) aged 60 to 87 years. Each patient underwent phacoemulsification with implantation of the OmniVu lens, after which they were followed for 36 months. Wiley and colleagues noted outcome measures including monocular and binocular uncorrected and corrected visual acuity at distance (4 m), intermediate (66 cm), and near (40 cm), in addition to manifest refraction spherical equivalent (MRSE).³

From 6 to 36 months, patients’ mean MRSE stayed within plus/minus 0.5 D. Mean refractive cylinder remained between –0.5 D and –1 D. By 36 months, mean monocular uncorrected distance, intermediate, and near visual acuities were recorded at 20/20, 20/20, and 20/27, respectively, while mean binocular uncorrected distance, intermediate, and near visual acuities were 20/17, 20/18, and 20/26, respectively.³

Additionally, early contrast sensitivity results from a substudy conducted at 6 months showed monocular mesopic performance comparable to published monofocal IOL literature. Investigators highlighted this as a notable finding for a presbyopia-correcting lens delivering a full range of vision.¹

Wiley and colleagues noted that the lens maintained stable refraction and sustained improvements in near vision. They believe that these results support its mechanistic durability and potential to mitigate presbyopia over a longer period following cataract surgery.²

“These 36-month results reinforce what we set out to prove, that patients should not have to choose between a continuous range of vision and long-term stability,” Mariam Maghribi, president and chief executive officer of Atia Vision, said in a statement. “We 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.”¹

References

1. Atia Vision announces durable 36-month results from first-in-human study of their dynamic shape-changing OmniVu Intraocular Lens System. News release. Atia Vision. April 14, 2026. Accessed April 15, 2026. https://www.businesswire.com/news/home/20260414715175/en/Atia-Vision-Announces-Durable-36-Month-Results-from-First-in-Human-Study-of-their-Dynamic-Shape-Changing-OmniVu-Intraocular-Lens-System

2. FDA grants Atia Vision approval to begin US clinical trial of OmniVu Lens System in patients with cataracts. News release. Atia Vision. May 20, 2025. Accessed April 15, 2026. https://atiavision.com/2025/05/20/fda-grants-atia-vision-approval-to-begin-us-clinical-trial-of-omnivu-lens-system-in-patients-with-cataracts/

3. Wiley W, Kurtanidze M, Agarwal A, et al. Durability of visual and refractive outcomes with a modular shape-changing IOL. Abstract presented at: 2026 ASCRS Annual Meeting; April 10-13, 2026; Washington, DC.