Clinical Outcomes of Patients Bilaterally Implanted with the Light Adjustable Lens: Results of a Phase IV Clinical Registry

Purpose: To report the outcomes of the Light Adjustable Lens (LAL) collected from a clinical registry. Setting: Multiple private practices in the United States. Design: Multi-center prospective observational study. Methods: Patients who underwent bilateral LAL implantation and who had best-corrected distance visual acuity (CDVA) ≥ 20/20 -2 before lens adjustment were enrolled. Assessment was performed at one visit 1-3 months after final lock-in treatment. Results: A total of 1101 participants (2202 eyes) were included. Of these, 586 eyes had prior corneal refractive surgery (CRS) and 1616 had no prior CRS (No CRS). 12.3% of participants were targeted for bilateral emmetropia, 9.3% for bilateral near and 78.4% for blended vision. Of eyes targeted for emmetropia, 81.2% achieved a UDVA of >20/20 (82.2% of No CRS and 78.4% of CRS). A total of 94.3% of eyes targeted for emmetropia had a MSE of <0.5D (94.7% of No CRS, 92.8% of CRS). The mean prediction error in MSE was -0.048 ± 0.366D in No CRS and -0.016 ± 0.441D in CRS. A total of 89% of patients with blended vision and 93% of patients with bilateral emmetropic target had binocular UCVA of >20/20. In the CRS, group 87% with blended vision and 87% with binocular emmetropia achieved binocular UCVA of >20/20. Binocular UNVA of >J1 was achieved with blended vision in 85% of patients in the No CRS group and 82% of patients in the CRS group. Conclusions: In this multi-center study, patients achieved a high degree of precision with the LAL regardless of prior corneal refractive surgery.