Objective:

To present three-year first-in-human data for the investigational OmniVu Lens System, emphasizing its investigational status and evaluating its refractive stability and visual outcomes.

Key Findings:

• Mean manifest refraction spherical equivalent remained within ±0.50 D over three years.
• Mean binocular uncorrected distance visual acuity at 36 months was -0.11 logMAR (approximately 20/16), with best-corrected distance acuity of -0.17 logMAR (about 20/12).
• 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.
• Only one YAG capsulotomy reported with no lens exchanges or refractive enhancements required.
• Contrast sensitivity data comparable to published monofocal IOL benchmarks.

Interpretation:

The OmniVu Lens System demonstrates sustained refractive stability and a broad functional range of vision, suggesting potential advantages in premium cataract surgery, particularly in presbyopia correction.

Limitations:

• The device is still investigational and not approved for sale, limiting generalizability.
• Limited sample size of 19 patients.

Conclusion:

The durability of outcomes from the OmniVu Lens System indicates a promising future for shape-changing, modular designs in presbyopia correction, potentially impacting the landscape of premium cataract surgery.