Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism
Abstract
1. Introduction
2. Materials and Methods
2.1. FDA Approval Timeline
2.2. Laser Specifications
2.3. PMA Cohorts
2.4. Outcome Measures
2.5. Selection of Published Studies
2.6. Statistical Analysis
3. Results
3.1. Patient Demographics
3.2. Efficacy
3.2.1. Myopia with and Without Astigmatism
3.2.2. Hyperopia with and Without Astigmatism
3.2.3. Mixed Astigmatism
3.3. Safety
3.4. Accuracy
3.5. Astigmatic Correction
3.6. Patient-Reported Outcomes
3.7. Retreatment
3.8. Complications
3.9. Review of Current Literature
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
LASIK | Laser assisted in situ keratomileusis |
FDA | Food and Drug Administration |
PMA | Premarket approval |
SSED | Summary of Safety and Effectiveness Data |
MRSE | Manifest refraction spherical equivalence |
CDVA | Corrected distance visual acuity |
UDVA | Uncorrected distance visual acuity |
ArF | Argon Fluoride |
CYL | Cylinder |
D | Diopter |
VA | Visual Acuity |
PROWL | Patient reported outcomes with LASIK |
FBS | Foreign body sensation |
DLK | Diffuse lamellar keratitis |
ANSI | American National Standards Institute |
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Zeiss | Alcon | ||||
---|---|---|---|---|---|
Excimer Laser | MEL80 | MEL90 | Allegretto Wave | Allegretto Wave Eye-Q | EX500 |
Approval (year) | 2006 | 2024 | 2003 | 2007 | 2010 |
Type | ArF | ArF | ArF | ArF | ArF |
Wavelength (nm) | 193 | 193 | 193 | 193 | 193 |
Frequency (Hz) | 250 | 500 | 200 | 400 | 500 |
Eye Tracker (Hz) | 250 | 1050 | 200 | 400 | 1050 |
Pulse Duration (ns) | 4–7 | 4–7 | 10 | 10 | 6 |
Optical Zone (mm) | 6.0–6.5 | 6.0–7.0 | 4.5–8.0 | 4.5–8.0 | 6.0–6.5 |
Ablation Zone (mm) | 9.2 a | 9.2 a | 9.0 | 9.0 | 9.0 |
Peak Fluence (mJ/cm2) | >150 | >150 | 400 | 400 | 400 |
MEL90 | EX500 | ||||||||
---|---|---|---|---|---|---|---|---|---|
Parameter | Myopia ± Astigmatism | Hyperopia ± Astigmatism | Mixed Astigmatism | Myopia ± Astigmatism | Hyperopia ± Astigmatism | Mixed Astigmatism | p d | p e | p f |
Eyes (n) | 358 | 221 | 135 | 901 | 290 | 162 | |||
Sex, male/female (n) | 88/95 | 52/65 | 46/31 | 436 b/465 b | 142 b/148 b | 109 b/53 b | |||
Age (years) a | 33.1 ± 7.5 (19 to 63) | 39.9 ± 11.5 (18 to 62) | 35.5 ± 9.1 (20 to 57) | 38.07 ± 9.7 (18 to 67) | 51.55 ± 8.8 (25 to 69) | 39.0 ± 9.4 (22 to 70) | <0.001 | <0.001 | 0.001 |
Preoperative MRSE (D) a | −5.14 ± 3.26 | 2.48 ± 1.83 | −0.04 ± 1.49 | −4.46 ± 2.35 c | 2.27 ± 1.30 c | −0.21 ± 0.05 c | <0.001 | 0.156 | 0.192 |
Preoperative CYL (D) a | −1.00 ± 1.05 (−4.00 to 0.00) | −0.99 ± 1.04 (−4.00 to 0.00) | −2.60 ± 0.99 (−4.00 to −0.75) | −0.85 ± 0.86 c (−5.00 to 0.00) | −0.66 ± 0.73 c (−4.50 to 0.00) | −2.40 ± 1.15 c (−6.00 to 0.00) | 0.017 | <0.001 | 0.110 |
MEL90 | EX500 | ||||||||
---|---|---|---|---|---|---|---|---|---|
Parameter (n/N) (%) | Myopia ± Astigmatism | Hyperopia ± Astigmatism | Mixed Astigmatism | Myopia ± Astigmatism | Hyperopia ± Astigmatism | Mixed Astigmatism | p c | p d | p e |
CDVA loss ≥ 2 lines | 1/342 (0.5%) | 0/210 (0%) | 0/133 (0%) | 6/818 (0.7%) | 4/260 (1.5%) | 1/111 (0.9%) | 0.131 | 0.455 | 0.681 |
CDVA worse than 20/40 a | 0/342 (0%) | 0/210 (0%) | 0/133 (0%) | 0/818 (0%) | 1/260 (0.4%) | 0/111 (0%) | NA | NA | NA |
CDVA worse than 20/25 a | 1/342 (0.5%) | 0/210 (0%) | 0/133 (0%) | 2/779 (0.3%) | 0/241 (0%) | 0/97 (0%) | 0.998 | NA | NA |
Increased CYL > 2.0 D | 0/342 (0%) | 0/210 (0%) | 1/133 (0.8%) | 0/242 b (0%) | 0/79 b (0%) | – | NA | NA | NA |
MEL90 | EX500 | |||||
---|---|---|---|---|---|---|
Complication n (%) | Myopia ± Astigmatism (n = 358) | Hyperopia ± Astigmatism (n = 221) | Mixed Astigmatism (n = 135) | Myopia ± Astigmatism (n = 876) | Hyperopia ± Astigmatism (n = 285) | Mixed Astigmatism (n = 161) |
Interface debris a | 13 (3.6) | 1 (0.5) | 0 | 0 | 0 | 0 |
Persistent FBS/pain | 0 | 1 (0.5) | 0 | 7 (0.8) | 5 (1.8) | 2 (1.2) |
Epithelium in interface | 4 (1.1) | 4 (1.8) | 0 | 3 (0.3) | 7 (2.5) | 0 |
Retinal detachment | 1 (0.3) | 0 | 0 | 0 | 1 (0.4) | 0 |
DLK | 6 (1.7) | 0 | 0 | 0 | 0 | 0 |
Corneal striae | 4 (1.1) | 0 | 0 | 0 | 0 | 0 |
Persistent corneal edema | 1 (0.3) | 2 (1.5) | 2 (1.5) | 0 | 0 | 0 |
Epithelial defect | 1 (0.3) | 0 | 0 | 16 (1.8) | 3 (1.0) | 0 |
Flap dislocation | 1 (0.3) | 0 | 0 | 2 (0.2) | 0 | 0 |
Flap tear/damage | 0 | 2 (0.9) a | 0 | 0 | 0 | 0 |
Study (Year) | Country | Follow-Up (mo) | N | MRSE, Mean ± SD | CYL ≤0.5 D | MRSE ±0.5 D | MRSE ±1.0 D | UDVA ≥20/20 | UDVA ≥20/40 | Loss of ≥2 Lines of CDVA | Loss of 1 Line of CDVA | No Change of CDVA | Gain of 1 Line of CDVA | Gain of ≥2 Lines of CDVA | Safety Index | Efficacy Index | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Preop (D) | Postop (D) | ||||||||||||||||
MEL90 | |||||||||||||||||
PMA trial (2024) [6] | US | 6 | 342 | −5.14 ± 3.26 | - | - | 93.0 | 98.8 | 86.3 | 98.8 | 0.5 | 3.2 | 71.9 | 22.2 | 2.4 | - | - |
Shehata et al. (2023) a [13] | EGY | 6 | 150 | −4.89 ± 0.77 | −0.05 ± 0.05 | - | 98.7 | - | 54 | - | - | - | - | - | - | - | - |
Vaswani et al. (2021) [14] | UK | 3 | 382 | - | - | 91 | 98 | 92 | - | 0 | - | - | - | - | - | - | |
Brar et al. (2021) [15] | IND | 12 | 165 | −3.98 ± 1.90 | −0.23 ± 0.23 | 97 | 91 | 100 | 96 | 100 | 0 | 3 | 59 | 35 | 3 | 1.08 | 1.00 |
Reinstein et al. (2015) [16] | UK | 3 | 286 | −3.83 ± 1.83 | −0.13 | 90 | 88 | 100 | 92 | 99 b | 0 | 6 | 59 | 31 | 4 | - | - |
EX500 | |||||||||||||||||
PMA trial (2003) [7] | US | 12 | 901 | −4.46 ± 2.35 | - | - | 85.1 | 97.7 | 87.4 | 99.0 | 0.5 | - | - | - | - | - | - |
Rowen et al. (2024) [17] | US | 3 | 121 | −4.35 ± 2.33 | −0.01 ± 0.24 | 92 | 96 | 100 | 95 | 100 | 0 | 8 | 69 | 23 | 0 | 1.05 c | 0.98 d |
Agarwal et al. (2018) [18] | AUS | 3 | 76 | −2.49 ± 1.00 | −0.09 ± 0.26 | - | 95 | - | 96.1 | 100 | 0 | 3 | 20 | 62 | 14 | 1.26 c | 1.12 d |
Niparugs et al. (2018) [19] | THA | 12 | 254 | −5.15 ± 2.41 | −0.14 ± 0.30 | 91.3 | 98.5 | 89.0 | 98.7 | 0 | 14.0 | 58.8 | 27.2 | 0 | - | - | |
Salés & Manche et al. (2013) [20] | US | 12 | 34 | −3.99 ± 1.71 | −0.33 ± 0.34 | 97 | 85 | 97 | 97 | 100 | 0 | 15 | 47 | 32 | 6 | - | - |
Study (Year) | Country | Follow-Up (mo) | N | MRSE, Mean ± SD | CYL ≤0.5 D | MRSE ±0.5 D | MRSE ±1.0 D | UDVA ≥20/20 | UDVA ≥20/40 | Loss of ≥2 Lines of CDVA | Loss of 1 Line of CDVA | No Change of CDVA | Gain of 1 Line of CDVA | Gain of ≥2 Lines of CDVA | Safety Index | Efficacy Index | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Preop (D) | Postop (D) | ||||||||||||||||
MEL90 | |||||||||||||||||
PMA trial (2024) [6] | US | 12 | 210 | 2.48 ± 1.83 | - | - | 82.9 | 96.7 | 48.6 | 98.1 | 0 | 9.1 | 77.1 | 12.9 | 1.6 | - | - |
Reinstein et al. (2018) [21] | UK | 12 | 1383 | 2.77 ± 1.34 | −0.11 ± 0.55 | 75 | 73 | 93 | 75 | 99 | 0.6 | 17 | 64 | 19 | 0 | - | - |
EX500 | |||||||||||||||||
PMA trial (2003) [8] | US | 12 | 290 | 2.27 ± 1.30 | - | - | 65.3 | 90.8 | 67.5 | 98.8 | 1.5 | - | - | - | - | - | - |
Moshirfar et al. (2021) [22] | US | 12 | 379 | 1.33 ± 1.10 | −0.46 ± 0.79 | 76 | 78 | 96 | 69 | 97 | 1.1 | 4.8 | 74 | 19 | 1.1 | 1.03 | 0.93 |
Durrie et al. (2009) [23] | US | 6 | 26 | 1.33 ± 0.76 | 0.16 ± 0.27 | - | 96.2 | 100 | 84 | 92 | 0 | 3.8 | 73.1 | 19.2 | 3.8 | - | - |
Study (Year) | Country | Follow-Up (mo) | N | MRSE, Mean ± SD | CYL ≤0.5 D | MRSE ±0.5 D | MRSE ±1.0 D | UDVA ≥20/20 | UDVA ≥20/40 | Loss of ≥2 Lines of CDVA | Loss of 1 Line of CDVA | No Change of CDVA | Gain of 1 Line of CDVA | Gain of ≥2 Lines of CDVA | Safety Index | Efficacy Index | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Preop (D) | Postop (D) | ||||||||||||||||
MEL90 | |||||||||||||||||
PMA trial (2024) [6] | US | 6 | 132 | −0.04 ± 1.49 | - | - | 92.4 | 97.7 | 68.9 | 100 | 0 | 3.8 | 75.2 | 19.6 | 1.6 | - | - |
Reinstein et al. (2018) [24] | UK | 12 | 105 | −0.30 ± 0.90 | −0.21 ± 0.38 | 65 | 85 | 99 | 73 | 94 | 0 | 10 | 57 | 32 | 1 | - | - |
EX500 | |||||||||||||||||
PMA trial (2003) [9] | US | 6 | 162 | −0.98 ± 0.80 | - | 78.4 | 91.0 | 97.3 | 69.4 | 97.3 | 0.9 | - | - | - | - | - | - |
Moshirfar et al. (2022) [25] | US | 12 | 179 | −0.61 ± 0.70 | −0.36 ± 0.57 | 80 | 88 | 100 | 74 | 100 | 0 | 3 | 72 | 25 | 0 | 1.02 a | 0.83 b |
Stonecipher et al. (2010) c [26] | US | 6 | 111 | 0.78 ± 0.52 | - | 100 | 95 | - | 79 | 99 | 0 | 10 | 50 | 40 | 0 | - | - |
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Brandenburg, T.M.; Sitto, M.M.; Hoopes, P.C.; Moshirfar, M. Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism. J. Clin. Med. 2025, 14, 5403. https://doi.org/10.3390/jcm14155403
Brandenburg TM, Sitto MM, Hoopes PC, Moshirfar M. Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism. Journal of Clinical Medicine. 2025; 14(15):5403. https://doi.org/10.3390/jcm14155403
Chicago/Turabian StyleBrandenburg, Traeson M., Mina M. Sitto, Phillip C. Hoopes, and Majid Moshirfar. 2025. "Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism" Journal of Clinical Medicine 14, no. 15: 5403. https://doi.org/10.3390/jcm14155403
APA StyleBrandenburg, T. M., Sitto, M. M., Hoopes, P. C., & Moshirfar, M. (2025). Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism. Journal of Clinical Medicine, 14(15), 5403. https://doi.org/10.3390/jcm14155403