Visual Outcomes and Safety of a Refractive Corneal Inlay for Presbyopia: One-Year Results

Purpose: To determine the visual outcomes and safety 12 months after implantation of the Presbia Flexivue Microlens refractive corneal inlay. Methods: In this prospective, non-randomized trial, 22 patients with a mean age of 52.54 ± 2.86 years were implanted with the Flexivue Microlens refractive corneal inlay in the non-dominant eye at the Department of Ophthalmology, Goethe University, Frankfurt, Germany. Corrected near, intermediate, and distance (CNVA, CIVA, and CDVA) visual acuity and uncorrected near, intermediate, and distance (UNVA, UIVA, and UDVA) visual acuity, manifest refraction, subjective quality of vision, endothelial cell count, and contrast sensitivity were measured 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. Results: For binocular CDVA, no patient lost two or more lines and 30% lost only one line at the 12-month visit. In the eye that had surgery, 85% of the patients lost two or more lines of UDVA, which was statistically significant. Sixty-five percent of the patients gained one or more lines in binocular UIVA, and 80% achieved 20/40 or better in DCIVA. UNVA showed a statistically significant improvement, with 90% of the patients achieving 20/40 or better 12 months after implantation. A total of 85% gained two or more lines in binocular UNVA. Conclusions: This refractive corneal inlay showed an improvement in binocular UNVA, UIVA, CNVA, and CIVA, whereas binocular CDVA and UDVA were not statistically affected. [ J Refract Surg . 2024;40(1):e1–e9.]