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

PURPOSE: To evaluate visual performance of a novel full range of vision spiral intraocular lens (IOL) designed with artificial intelligence using preclinical and clinical metrics. METHODS: Preclinical visual performance was assessed in healthy individuals using a pseudophakic vision simulation device, comparing monocular corrected distance visual acuity, contrast sensitivity, defocus curve, halo/glare size, and subjective preference between the spiral RayOne Galaxy IOL and diffractive RayOne Trifocal IOL (Rayner). Additionally, postoperative clinical outcomes were subsequently analyzed from 10 sites following bilateral RayOne Galaxy IOL implantation. At 3 months postoperatively, key endpoints included subjective refraction, monocular and binocular uncorrected and corrected distance visual acuity at multiple distances, defocus curves, and patient-reported dysphotopsia. RESULTS: Preclinical evaluation demonstrated comparable range of focus between the Galaxy and diffractive Trifocal IOLs. However, the Galaxy IOL exhibited significantly less halo/glare, with nearly all participants preferring it across all distances. In the clinical study, mean monocular corrected distance visual acuities were -0.03 ± 0.08 logarithm of the minimum angle of resolution (logMAR) for distance, 0.05 ± 0.11 logMAR for intermediate, and 0.08 ± 0.14 logMAR for near, with further improvement observed binocularly. Monocular/binocular defocus curves demonstrated a smooth plateau with binocular defocus maintaining visual acuity of 20/32 (0.2 logMAR) or better from +1.00 to -2.80 diopters (35 cm). Halo and glare symptoms were generally minor (> 95% of patients), with no severe cases. CONCLUSIONS: The Galaxy IOL provides excellent monocular and binocular visual acuity across all tested distances, with a smooth and continuous defocus curve ensuring full-range vision. Preclinical testing demonstrated significantly fewer photic phenomena than the tested diffractive trifocal IOL, whereas clinical investigations found no indications of bothersome side effects, together demonstrating high visual comfort.