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Femtosecond lenticule extraction for the correction of myopia: preliminary 6-month results

  • Refractive Surgery
  • Published:
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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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This study was supported by Carl Zeiss Meditec, Germany.

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Marcus Blum.

Additional information

The authors have no financial interest in any technology mentioned.

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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