Journal of cataract and refractive surgery · 2026
Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Holladay Jack T, Haller Matt
Аннотация
PURPOSE: To compare the outcomes of spherical equivalent (SEQ) and residual astigmatism between the light-adjustable lens (LAL) from the U.S. Food and Drug Administration postapproval study (PAS) and 2 contemporary toric intraocular lens (IOL) studies.
SETTING: 6, 14, and 20 surgical sites across the United States.
DESIGN: Randomized prospective case series.
METHODS: The LAL patient population comprised 332 adults with preexisting corneal astigmatism. 2 contemporary astigmatic control datasets were selected for comparison. The first dataset included 111 eyes that received an aspheric toric monofocal AcrySof IQ IOL (SN6AT). The second dataset consisted of 101 eyes treated with an aspheric toric monofocal enVista IOL (MX60ET) as part of ClinicalTrials.gov (NCT05739656).
RESULTS: For the LAL group, the mean absolute error (MAE) of residual astigmatism was 0.26 ± 0.27 diopters (D), compared with 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. 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 UDVA and enhanced patient satisfaction.
SETTING: 6, 14, and 20 surgical sites across the United States.
DESIGN: Randomized prospective case series.
METHODS: The LAL patient population comprised 332 adults with preexisting corneal astigmatism. 2 contemporary astigmatic control datasets were selected for comparison. The first dataset included 111 eyes that received an aspheric toric monofocal AcrySof IQ IOL (SN6AT). The second dataset consisted of 101 eyes treated with an aspheric toric monofocal enVista IOL (MX60ET) as part of ClinicalTrials.gov (NCT05739656).
RESULTS: For the LAL group, the mean absolute error (MAE) of residual astigmatism was 0.26 ± 0.27 diopters (D), compared with 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. 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 UDVA and enhanced patient satisfaction.