Performance of the First Spiral Refractive Intraocular Lens for Continuous Full Range of Vision

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Optics

Background:

• Intraocular lenses (IOLs) are crucial for vision correction after cataract surgery.
• Current IOLs aim to provide clear vision at multiple distances, but may have limitations like glare or halos.
• Advancements in IOL design, including AI-driven approaches, seek to improve visual performance and patient comfort.

Purpose of the Study:

• To evaluate the visual performance of a novel, AI-designed, full-range-of-vision spiral intraocular lens (IOL) called the RayOne Galaxy.
• To compare its preclinical and clinical outcomes against a standard diffractive trifocal IOL.

Main Methods:

• Preclinical assessment using a pseudophakic vision simulation device to compare visual acuity, contrast sensitivity, defocus curves, and halo/glare.
• Clinical analysis of 10 sites following bilateral RayOne Galaxy IOL implantation, measuring refraction, visual acuity (distance, intermediate, near), defocus curves, and patient-reported dysphotopsia at 3 months.

Main Results:

• Preclinical tests showed comparable focus range to trifocal IOLs but significantly less halo/glare, with high participant preference for the Galaxy IOL.
• Clinical outcomes demonstrated excellent monocular and binocular visual acuity across distances (e.g., distance: -0.03 ± 0.08 logMAR).
• Defocus curves showed a smooth plateau, maintaining good vision from +1.00 to -2.80 diopters; photic phenomena were minor in over 95% of patients.

Conclusions:

• The RayOne Galaxy IOL delivers excellent visual acuity and a continuous defocus curve for full-range vision.
• Preclinical and clinical data indicate significantly reduced photic phenomena and high visual comfort compared to diffractive trifocal IOLs.
• The AI-designed spiral IOL demonstrates a promising alternative for achieving high visual quality and comfort.