Abstract
Purpose
To report the 6-month results of a new method of refractive correction, femtosecond lenticule extraction (FLEx), and the preliminary outcomes in the first 108 eyes.
Methods
In this prospective study, a flap and a lenticule of intrastromal corneal tissue were cut simultaneously using a femtosecond laser. Thereafter, the lenticule was removed manually and the flap repositioned. One hundred and seven of 108 myopic eyes of 56 patients in the treatment group completed the final 6 months of follow-up. The patients’ mean age was 35 years. The preoperative mean spherical equivalent (SE) was −4.59 ± 1.3 diopters (D). The uncorrected visual acuity and the best spectacle-corrected visual acuity after 6 months, objective and manifest refractions, results of slit-lamp examination, the side effects, and the responses to a questionnaire are reported.
Results
Six months postoperatively, the mean SE was −0.19 ± 0.47 D; 98.1% of treated eyes were within ±1.0 D, and 74.8% of eyes within ±0.5 D of the intended correction. Eight (7.4%) of 108 eyes lost one line of Snellen VA, one (0.9%) eye lost two Snellen lines, 46 eyes (43%) gained one line, ten eyes (9.3%) gained two Snellen lines, and the VA remained unchanged in 42 (39.3%) eyes. The patient responses to a standardized questionnaire indicated that 97.1% of patients were satisfied with the obtained results and would undergo the procedure again.
Conclusion
FLEx appears to be a safe and promising corneal refractive procedure for correcting myopia.










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Barraquer JI (1996) The history and evolution of keratomileusis. Int Ophthalmol Clin 36:1–7
Ibrahim O, Waring GO, Salah T, el Maghraby A (1995) Automated in situ keratomileusis for myopia. J Refract Surg 11:431–441
Wiegand W, Krusenberg B, Kroll P (1995) Keratomileusis in situ bei hochgradiger Myopie. Erste Ergebnisse. Ophthalmologe 92:402–409
Sekundo W (2007) Refraktive Chirurgie. In: Augustin AJ (ed) Augenheilkunde. Springer, Heidelberg, New York, Tokyo, pp 823–845
Nordan LT, Slade SG, Baker RN (2003) Femtosecond laser flap creation for laser in situ keratomileusis: six-months follow-up of the initial US clinical series. J Refract Surg 19:8–14
Ratkay-Traub I, Ferincz IE, Juhasz T, Kurtz RM, Krueger RR (2003) First clinical results with the femtosecond neodymium–glass laser in refractive surgery. J Refract Surg 19:94–103
Krueger RR, Juhasz T, Gualano A, Marchi V (1998) The picosecond laser for nonmechanical laser in situ keratomileusis. J Refract Surg 14:467–469
Sekundo W, Kunert K, Russmann Ch et al (2008) First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia. J Cataract Refract Surg 34:1513–1520
Durrie DS, Kezirian GM (2005) Femtosecond laser versus mechanical keratome flaps in wavefront-guided laser in situ keratomileusis: prospective contralateral eye study. J Cataract Refract Surg 31:120–126
Tran DB, Sarayba MA, Bor Z et al (2005) Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis. J Cataract Refract Surg 31:97–105
Binder PS (2004) Flap dimensions created with the IntraLase FS laser. J Cataract Refract Surg 30:804–811
Biser SA, Bloom AH, Donnenfeld ED et al (2003) Flap folds after femtosecond LASIK. Eye Contact Lens 29:252–254
Muňoz G, Albarran-Diego C, Sakla FH et al (2006) Transient light-sensitivity syndrome after laser in situ keratomileusis with the femtosecond laser. J Cataract Refract Surg 32:2075–2079
Steinert RF, Ignacio TS, Sarayba MA (2007) “Top hat”-shaped penetrating keratoplasty using the femtosecond laser. Am J Ophthalmol 143:689–691
Ertan A, Kamburoğlu G (2007) Analysis of centration of Intacs segments implanted with a femtosecond laser. J Cataract Refract Surg 33:484–487
Dupps WJ, Oberts C (2001) Effect of acute biomechanical changes on corneal curvature after photokeratectomy. J Refract Surg 17:658–669
Goes F (2005) LASIK for myopia with the Zeiss Meditec MEL 80. J Refract Surg 21:691–697
Blum M, Kunert K, Gille A, Sekundo W (2009) LASIK for myopia using the Zeiss VISUMAX® femtosecond laser and MEL 80 excimer laser. J Refract Surg 25:350–356
Kezirian GM, Stonecipher KG (2004) Comparison of the IntraLase femtosecond laser and mechanical microkeratome for laser in situ Keratomileusis. J Cataract Refract Surg 30:26–32
Reviglio VE, Kuo IC, Gramajo L et al (2007) Acute rhegmatogenous retinal detachment immediately following laser in situ keratomileusis. J Cataract Refract Surg 33:536–359
This study was supported by Carl Zeiss Meditec, Germany.
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Appendix
Appendix
Percentage [%]/share/total number of eyes | ||||
Problem | Pre-op | Post-op | ||
1 month | 3 months | 6 months | ||
1. Light sensitivity | ||||
None | 75.0%/81/108 | 50.5%/54/107 | 58.5%/62/106 | 67.5%/69/105 |
Mild | 17.6%/19/108 | 39.3%/42/107 | 33.0%/35/106 | 26.7%/28/105 |
Moderate | 5.6%/6/108 | 10.3%/11/107 | 6.6%/7/106 | 3.8%/4/105 |
Significant | 1.9%/2/108 | 0.0%/0/107 | 1.9%/2/106 | 3.8%/4/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
2. Headache | ||||
None | 85.2%/92/108 | 94.4%/101/107 | 91.5%/97/106 | 88.6%/93/105 |
Mild | 11.1%/12/108 | 1.9%/2/107 | 4.7%/5/106 | 8.6%/9/105 |
Moderate | 1.9%/2/108 | 3.7%/4/107 | 3.8%/4/106 | 2.9%/3/105 |
Significant | 1.9%/2/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
3. Pains/burning | ||||
None | 92.6%/100/108 | 87.9%/94/107 | 84.9%/90/106 | 86.7%/91/105 |
Mild | 7.4%/8/108 | 10.3%/11/107 | 13.2%/14/106 | 11.4%/12/105 |
Moderate | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Significant | 0.0%/0/108 | 1.9%/2/107 | 1.9%/2/106 | 1.9%/2/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
4. Dryness | ||||
None | 86.1%/93/108 | 41.1%/44/107 | 43.4%/46/106 | 56.2%/59/105 |
Mild | 13.9%/15/108 | 51.4%/55/107 | 44.3%/47/106 | 32.4%/34/105 |
Moderate | 0.0%/0/108 | 6.5%/7/107 | 10.4%/11/106 | 8.6%/9/105 |
Significant | 0.0%/0/108 | 0.9%/1/107 | 1.9%/2/106 | 1.9%/2/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 1.0%/1/105 |
5. Continuous tear production | ||||
None | 97.2%/105/108 | 98.1%/43/107 | 100%/106/106 | 98.1%/103/105 |
Mild | 2.8%/5/108 | 1.9%/1/107 | 0.0%/0/106 | 1.9%/2/105 |
Moderate | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Significant | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
6. Itching | ||||
None | 97.2%/105/108 | 83.2%/89/107 | 87.7%/93/106 | 87.6%/92/105 |
Mild | 2.8%/3/108 | 16.8%/18/107 | 12.3%/13/106 | 12.4%/13/105 |
Moderate | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Significant | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
7. Glare | ||||
None | 82.4%/89/108 | 59.8%/64/107 | 65.1%/69/106 | 70.5%/74/105 |
Mild | 12.0%/13/108 | 35.5%/38/107 | 29.2%/31/106 | 23.8%/25/105 |
Moderate | 5.6%/6/108 | 4.7%/5/107 | 3.8%/4/106 | 2.9%/3/105 |
Significant | 0.0%/0/108 | 0.0%/0/107 | 1.9%/2/106 | 2.9%/3/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
8. Haloes around lights | ||||
None | 91.7%/99/108 | 53.3%/57/107 | 57.5%/61/106 | 57.1%/60/105 |
Mild | 4.6%/5/108 | 33.6%/36/107 | 29.2%/31/106 | 25.7%/27/105 |
Moderate | 1.9%/2/108 | 10.3%/11/107 | 7.5%/8/106 | 11.4%/12/105 |
Significant | 1.9%/2/108 | 2.8%/3/107 | 3.8%/4/106 | 5.7%/6/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 1.9%/2/106 | 0.0%/0/105 |
9. Distorted vision | ||||
None | 97.2%/105/108 | 85.0%/91/107 | 92.5%/98/106 | 91.4%/96/105 |
Mild | 2.8%/3/108 | 12.1%/13/107 | 6.5%/7/106 | 7.6%/8/105 |
Moderate | 0.0%/0/108 | 1.9%/2/107 | 0.9%/1/106 | 1.0%/1/105 |
Significant | 0.0%/0/108 | 0.9%/1/107 | 0.0%/0/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
10. Double vision | ||||
None | 100%/108/108 | 95.3%/102/107 | 94.3%/100/106 | 96.2%/101/105 |
Mild | 0.0%/0/108 | 4.7%/5/107 | 3.8%/4/106 | 2.9%/3/105 |
Moderate | 0.0%/0/108 | 0.0%/0/107 | 1.9%/2/106 | 0.0%/0/105 |
Significant | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 1.0%/1/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
11. Vision fluctuations | ||||
None | 89.9%/97/108 | 49.5%/53/107 | 60.4%/64/106 | 63.8%/67/105 |
Mild | 8.3%/9/108 | 36.4%/39/107 | 29.2%/31/106 | 31.4%/33/105 |
Moderate | 1.9%/2/108 | 10.3%/11/107 | 9.4%/10/106 | 2.9%/3/105 |
Significant | 0.0%/0/108 | 3.7%/4/107 | 0.9%/1/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 1.9%/2/105 |
12. Changed vision | ||||
In sunlight | ||||
None | 88.0%/95/108 | 71.0%/76/107 | 76.4%/81/106 | 83.8%/88/105 |
Mild | 10.2%/11/108 | 25.2%/27/107 | 20.8%/22/106 | 16.2%/17/105 |
Moderate | 1.9%/2/108 | 2.8%/3/107 | 1.9%/2/106 | 0.0%/0/105 |
Significant | 0.0%/0/108 | 0.0%/0/107 | 0.9%/1/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
In room lighting | ||||
None | 90.7%/98/108 | 76.6%/82/107 | 78.3%/83/106 | 84.8%/89/105 |
Mild | 9.3%/10/108 | 16.8%/18/107 | 18.9%/20/106 | 14.3%/15/105 |
Moderate | 0.0%/0/108 | 5.6%/6/107 | 2.8%/3/106 | 1.0%/1/105 |
Significant | 0.0%/0/108 | 0.9%/1/107 | 0.0%/0/106 | 0.0%/0/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
In the dark | ||||
None | 75.9%/82/108 | 71.0%/76/107 | 67.9%/72/106 | 68.6%/72/105 |
Mild | 21.3%/23/108 | 17.8%/19/107 | 25.5%/27/106 | 26.7%/28/105 |
Moderate | 2.8%/3/108 | 8.4%/9/107 | 5.7%/6/106 | 2.9%/3/105 |
Significant | 0.0%/0/108 | 2.8%/3/107 | 0.9%/1/106 | 1.9%/2/105 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/105 |
13. Problems when driving at night | ||||
None | 81.5%/88/108 | 71.0%/76/107 | 67.0%/71/106 | 74.3%/78/104 |
Mild | 13.9%/15/108 | 18.7%/20/107 | 23.6%/25/106 | 19.0%/20/104 |
Moderate | 4.6%/5/108 | 8.4%/9/107 | 5.7%/6/106 | 3.8%/4/104 |
Significant | 0.0%/0/108 | 1.9%/2/107 | 3.8%/4/106 | 2.9%/3/104 |
Severe | 0.0%/0/108 | 0.0%/0/107 | 0.0%/0/106 | 0.0%/0/104 |
14. Others | ||||
None | 100%/108/108 | 97.2%/104/108 | 100%/106/106 | 98.1%/103/104 |
Mild | 0.0%/0/108 | 1.9%/2/108 | 0.0%/0/106 | 1.9%/2/104 |
Moderate | 0.0%/0/108 | 0.0%/0/108 | 0.0%/0/106 | 0.0%/0/104 |
Significant | 0.0%/0/108 | 0.0%/0/108 | 0.0%/0/106 | 0.0%/0/104 |
Severe | 0.0%/0/108 | 0.0%/0/108 | 0.0%/0/106 | 0.0%/0/104 |
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Blum, M., Kunert, K., Schröder, M. et al. Femtosecond lenticule extraction for the correction of myopia: preliminary 6-month results. Graefes Arch Clin Exp Ophthalmol 248, 1019–1027 (2010). https://doi.org/10.1007/s00417-009-1293-1
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DOI: https://doi.org/10.1007/s00417-009-1293-1