Table 4.
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.