International Multicenter, Myopic and Myopic Astigmatism Femto LASIK, Customized by Automated Ray-Tracing Ablation Profile Calculation: A Postmarket Study

Figures & data

Table 1 Demographics and Baseline Characteristics

Parameter	InnovEyes
Demographics^a
No. of patients	112
Age (years), mean ± SD (range)	30.3±4.88 (22 to 42)
Sex, n (%)
Female	64 (57.1)
Male	48 (42.9)
Race and ethnicity, n (%)
Asian	26 (23.2)
Black or African American	1 (0.9)
White	81 (72.3)
Other	4 (3.6)
Baseline characteristics^b
No. of patients (eyes)	111 (222)
UDVA (logMAR), mean ± SD (range)	0.887±0.291 (0.10 to 1.64)
CDVA (logMAR), mean ± SD (range)	−0.083±0.071 (−0.28 to 0.04)
MRSE (D), mean ± SD (range)	−3.38±1.76 (−8.63 to −0.63)
Manifest refraction sphere (D), mean ± SD (range)	−3.019±1.764 (−8.50 to 0)
Manifest refraction sphere by bin, n/N (%)
0 to ≤−1.0 D	28/222 (12.6)
>−1.0 to ≤−2.0 D	48/222 (21.6)
>−2.0 to ≤−3.0 D	53/222 (23.9)
>−3.0 to ≤−4.0 D	44/222 (19.8)
>−4.0 to ≤−5.0 D	18/222 (8.1)
>−5.0 to ≤−6.0 D	14/222 (6.3)
>−6.0 to ≤−7.0 D	11/222 (5.0)
>−7.0 to ≤−8.0 D	5/222 (2.3)
>−8.0 to ≤−9.0 D	1/222 (0.5)
>−9.0 to ≤−11.0 D	0
Manifest refraction cylinder (D), mean ± SD (range)	−0.712±0.609 (−3.25 to 0)
Manifest refraction cylinder by bin, n/N (%)
0 to ≤−0.50 D	122/222 (55.0)
>−0.50 to ≤−1.00 D	57/222 (25.7)
>−1.00 to ≤−2.00 D	35/222 (15.8)
>−2.00 to ≤−3.00 D	7/222 (3.2)
>−3.00 to ≤−4.00 D	1/222 (0.5)
>−4.00 to ≤−4.50 D	0

Notes: ^aDemographic data are from all patients who underwent successful surgery (112 patients). ^bBaseline characteristics are from all patients/eyes that were included in the FAS (111 patients; 222 eyes) and exclude 1 patient who was successfully treated bilaterally but was pregnant at screening, which was not reported until the patient was seen at the postoperative visit.

Abbreviations: CDVA, best-corrected distance visual acuity; D, diopter; FAS, full analysis set; logMAR, logarithm of the minimum angle of resolution; MRSE, manifest refraction spherical equivalent; SD, standard deviation; UDVA, uncorrected distance visual acuity.

Figure 1 Refractive and visual outcomes at Month 3.

Notes: (A) Cumulative postoperative UDVA compared with preoperative CDVA. (B) Line difference between postoperative UDVA and preoperative CDVA. A line is 0.1 logMAR. (C) Change in lines between preoperative and postoperative CDVA. (D) Attempted versus achieved spherical equivalent refraction. (E) Spherical equivalent refraction accuracy. (F) MRSE stability at screening, Week 1, Month 1, and Month 3. (G) Refractive astigmatism. (H) Target‑induced astigmatism versus surgically induced astigmatism. (I) Refractive astigmatism angle of error. For panels showing the proportion of eyes, for clarity, numbers ≥1 are displayed as integers and those <1 are shown to 1 decimal place, and in all cases, the total is 100%.

Abbreviations: Abs, absolute; Arith, arithmetic; CDVA, corrected distance visual acuity; C/Wise, clockwise; CC/Wise, counterclockwise; D, diopter; logMAR, logarithm of the minimum angle of resolution; mo, month; MRSE, manifest refraction spherical equivalent; postop, postoperative; preop, preoperative; SD, standard deviation; SEQ, spherical equivalent refraction; SIA, surgically induced astigmatism; TIA, target-induced astigmatism; UDVA, uncorrected distance visual acuity; VA, visual acuity; wk, week.

Figure 2 Astigmatism vector analyses at Month 3.

Notes: Vector analyses of (A) target-induced astigmatism, (B) surgically induced astigmatism, (C) difference vector, and (D) correction index.

Abbreviations: Arith, arithmetic; Ax, axis; cyl, cylinder; D, diopter; Geom, geometric; SD, standard deviation; +ve, positive.

Table 2 Higher-Order Aberrations

Parameter	Preoperative (n=222)	Month 3 (n=209)	Change
Trefoil (μm), mean ± SD (range)	0.052±0.029 (0 to 0.16)	0.045±0.028 (0 to 0.16)	−0.005±0.039 (−0.13 to 0.13)
Coma (μm), mean ± SD (range)	0.048±0.024 (0 to 0.14)	0.063±0.042 (0.01 to 0.27)	0.015±0.045 (−0.08 to 0.25)
Spherical aberration (μm), mean ± SD (range)	0.025±0.022 (−0.04 to 0.11)	−0.007±0.033 (−0.11 to 0.07)	−0.032±0.033 (−0.15 to 0.04)
Total higher-order aberrations (RMSh) (μm), mean ± SD (range)	0.104±0.033 (0.05 to 0.31)	0.107±0.042 (0.01 to 0.32)	0.004±0.047 (−0.22 to 0.24)

Abbreviations: RMSh, root mean square of higher-order aberrations; SD, standard deviation.

Figure 3 Patient satisfaction at Month 3.

Notes: Detailed responses from the PROWL questionnaire on current satisfaction with results of Femto LASIK surgery and happiness/unhappiness that they had Femto LASIK surgery (n=106 patients).

Abbreviations: Femto LASIK, femtosecond-assisted LASIK; LASIK, laser-assisted in situ keratomileusis; PROWL, patient-reported outcomes with LASIK.