Light Adjustable Lens Results of Spherical Equivalent and Astigmatism Correction from the FDA Post-Approval Study

Purpose: To compare the outcomes of spherical equivalent and residual astigmatism between the Light Adjustable Lens (LAL) from the Post Approval Study (PAS) and two contemporary toric intraocular lens (IOL) studies. Setting: Six, fourteen, and twenty surgical sites across the United States. Design: Randomized prospective case series. Methods: The LAL patient population comprised 332 adults with pre-existing corneal astigmatism. Two contemporary astigmatic control datasets were selected for comparison. The first dataset included 111 eyes that received an aspheric toric monofocal AcrySof IQ IOL (SN6AT, Alcon, Inc.). The second dataset consisted of 101 eyes treated with an aspheric toric monofocal enVista IOL (MX60ET, Bausch & Lomb, Inc.) as part of ClinicalTrials.gov NCT05739656. Results: For the LAL group, the Mean Absolute Error (MAE) of residual astigmatism was 0.26 ± 0.27 D, compared to 0.36 ± 0.35 D for the SN6AT group and 0.38 ± 0.38 D for the MX60ET group. The percentage of cases with residual astigmatism ≤ |0.50| D was 92.5% for LAL, 76.6% for SN6AT, and 76.2% for MX60ET. Spherical equivalent (SEQ) within ≤ |0.50| D was achieved in 93.1% of LAL cases, 83.8% of SN6AT cases, and 87.1% of MX60ET cases. Uncorrected Distance Visual Acuity (UDVA) was -0.02 (20/19) for LAL, 0.08 (20/24) for SN6AT, and 0.10 (20/25) for MX60ET. Conclusions: Postoperative adjustment capability of the LAL enables significant reduction in residual astigmatism and SEQ, contributing to improved uncorrected distance visual acuity and enhanced patient satisfaction.