Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six Month Results from the United States Food and Drug Administration Clinical Trial

Figures & data

Figure 1 Scatter plot of attempted versus achieved correction of manifest refraction spherical equivalent, demonstrating the full range of refractive correction.

Table 1 Preoperative Characteristics

	Subjects (N = 327)
Gender, n (%)
Male	114 (34.9)
Female	213 (65.1)
Race, n (%)
Caucasian	274 (83.8)
African American/Black	11 (3.4)
Asian	38 (11.6)
Native Hawaiian or Other Pacific Islander	3 (0.9)
American Indian or Alaska Native	1 (0.3)
Ethnicity, n (%)
Hispanic or Latino	34 (10.4)
Not Hispanic or Latino	293 (89.6)
Age, years
Mean (SD)	35.6 (5.09)
Median	36.0
Minimum, maximum	22, 45
	Eyes (N=629)
Manifest refraction sphere (D)
Mean (SD)	−7.128 (2.7435)
Median	−6.750
Min, Max	−15.00, −1.75
Manifest refraction cylinder^a (D)
N	547
Mean (SD)	−1.139 (0.8929)
Median	−0.750
Min, Max	−4.00, −0.25
Manifest refraction spherical equivalent (D)
Mean (SD)	−7.623 (2.7580)
Median	−7.380
Min, Max	−15.62, −3.00
Endothelial cell density (cells/mm^2)
Mean (SD)	2948.0 (268.10)
Median	2959.7
Min, Max	2119, 3797
Intraocular pressure (mmHg)
Mean (SD)	15.9 (2.83)
Median	16.0
Min, Max	9, 22

Notes: ^aAll cylinder measurements are reported in the negative scale; subjects with a reported cylinder value of 0.00 D are not included in summary statistics.

Figure 2 Accuracy of spherical equivalent refractive correction at Month 6. 90.5% of eyes were within ± 0.50 D and 98.9% of eyes were within ± 1.00 D of emmetropia.

Figure 3 The stability of the spherical equivalent refraction from Month 1 to Month 6 is demonstrated in the consistent cohort of 617 eyes with data at all time points.

Figure 4 Frequency distribution of uncorrected visual acuity at Month 6. All visual acuity testing was performed using an ETDRS chart and values were converted from logMAR to Snellen.

Figure 5 Lines of corrected distance visual acuity gained or lost. 52.3% of eyes gained lines of CDVA and 98.5% of eyes demonstrated CDVA at 6 months equal to or better than preoperative CDVA.

Figure 6 Mean postoperative intraocular pressure remained stable from Day 1 through Month 6.

Figure 7 Vault measurements were consistent with values previously reported in the published literature.