Visual And Refractive Outcomes, Contrast Sensitivity And Patient-Reported Outcomes At Three Months After Bilateral Implantation Of An Ai-Designed Spiral Full-Range Focus Intraocular Lens

To evaluate the clinical performance of a full-range focus intraocular lens with AI-designed spiral optics by assessing visual and refractive outcomes, defocus curve, contrast sensitivity, and patient-reported outcomes at three months following bilateral implantation.

Clinica Baviera Aier Group, Valencia, Spain

This prospective study included 110 patients who underwent bilateral cataract or refractive lens exchange surgery with implantation of the RayOne Galaxy IOL. Postoperative assessments were conducted at three months. Visual acuity was measured monocularly and binocularly at different distances: uncorrected distance (UDVA) and corrected distance (CDVA) at 4 m, uncorrected intermediate (UIVA) and distance-corrected intermediate (DCIVA) at 66 cm, and uncorrected near (UNVA) and distance-corrected near (DCNVA) at 40 cm. Defocus curve and contrast sensitivity (CS) were assessed binocularly. Patient-reported outcome measures (PROMs) included CatQUEST-9SF, QUVID, RayPRO, and a self-developed patient questionnaire.

At three months, mean binocular visual acuity (VA) (logMAR) was: UDVA 0.00 ± 0.04 and CDVA −0.01 ± 0.03; UIVA 0.06 ± 0.06 and DCIVA 0.06 ± 0.06; UNVA 0.10 ± 0.07 and DCNVA 0.10 ± 0.07. Overall, 100% achieved binocular VA ≥0.2 logMAR at distance and intermediate, and 97% at near. Binocular defocus curve showed a smooth plateau maintaining VA ≥0.2 logMAR across ~4.0 D range, with mean VA values of −0.01 ± 0.03 logMAR at far, 0.02 ± 0.04 logMAR at intermediate, and 0.13 ± 0.07 logMAR at near.  Binocular CS at 3, 6, 12, and 18 cycles per degree was 2.08 ± 0.02, 2.16 ± 0.15, 1.83 ± 0.19, and 1.45 ± 0.26 log units, respectively. PROMs indicated low impact of dysphotopsias, high levels of satisfaction and spectacle independence.

Binocular visual acuity at three months was excellent at distance, intermediate, and near. The results demonstrate that the Galaxy IOL with a unique spiral design provides high visual quality across multiple distances. Patient-reported outcomes indicate high levels of satisfaction and spectacle independence, supporting the lens as an effective option for achieving functional vision comparable to diffractive trifocal IOLs.