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. 2021 Jul 6;15:2893–2906. doi: 10.2147/OPTH.S321095

Table 4.

Toric ICL Outcomes Compared Between the Present Study and the Literature

Study Year Eyes Time MRSE ± SD (Range) D Abs MRC* ± SD Range) D UDVA 20/20 or Better (%) % MRSE/MRC ± 0.50 D Intended % MRSE/MRC ±1.00 D Intended Safety Index Efficacy Index
Present study 2021 96 Preop −10.31 ± 3.10 (−4.88 to −21.75) 2.67 ± 1.02 (1.50 to 5.75)
75 3 mo −0.33 ± 1.12 (−6.75 to +2.00) 0.68 ± 0.38 (0.00 to 1.50) 62 77/44 95/89 1.14 0.92
46 12 mo −0.23 ± 0.47 (−1.25 to 1.50) 0.73 ± 0.51 (0.25 to 3.00) 74 79/49 93/86 1.10 0.98
FDA Clinical Endpoints8 2018 50/40 75/65
FDA Clinical Trial8 2018 210 Preop −9.37 ± 2.67 (−2.38 to −19.50) 1.95 ± 0.84 (1.00 to 4.00)
191 3 mo 0.13 ± 0.39 (−1.25 to +1.25) 0.52 ± 0.49 (0.00 to 3.00)
194 12 mo 0.03 ± 0.46 (−2.25 to +1.00) 0.52 ± 0.48 (0.00 to 3.00) 81.9 76.9/69.1 97.4/92.3
Sanders et al5 2007 200 Preop −9.36 ± 2.66 1.93 ± 0.84
175 6 mo 71.3/53.4 97.1/86.2
186 12 mo 0.05 ± 0.46 0.51 ± 0.48 83.1 76.9/48.4 97.3/85.5
Hyun et al14 2017 24 Preop −10.68 ± 2.44 (−5.57 to −15.68) 2.50 ± 1.24 (1.00 to 5.25)
Postop −0.41 ± 0.48 (−1.50 to 0.56) 0.63 ± 0.33 (0.00 to 1.25) 62.5 1.14 1.06
Kamiya et al6 2013 50 Preop −9.47 ± 2.91 (−3.00 to −17.25) 2.23 ± 1.09 (0.75 to 6.50)
3 mo 0.05 ± 0.22 0.50 ± 0.43 94 1.21 1.02
12 mo −0.11 ± 0.32 0.57 ± 0.60 90 1.23 1.03
36 mo −0.22 ± 0.37 0.49 ± 0.41 86 82/92 98/94 1.16 0.94
Sheng et al30 2012 54 Preop −12.08 ± 4.22 (−6.00 to −24.75) 1.88 ± 1.49 (1.00 to 5.50)
8 mo −0.41 ± 0.61 0.41 ± 0.61 72.2%

Note: *MRC reported as absolute magnitude for comparison across studies.

Abbreviations: UDVA, uncorrected distance visual acuity; MRSE, manifest refraction spherical equivalent; D, diopter; MRC, manifest refractive cylinder.