FDA Results

The Summit Apex Excimer Laser System 

The FDA approval of the Summit Apex Excimer Laser System was based in part on information obtained from 1,600 eyes that underwent laser vision correction as part of the clinical trials with the device. These eyes were followed for 3 years after treatment.

The following information highlights some of the data on 341 eyes using a 6mm treatment zone (the current standard):

  • at 6 months 95% could see 20/40 or better without glasses
  • at 6 months 66% could see 20/20 or better without glasses
  • at 1 year 98.8 % were able to obtain the same or better pre-operative vision either with or without glasses
  • at 1 year 1.2% of patients had lost 2 lines of vision
    (e.g. vision decreased from a pre-operative level from 20/20 to 20/40)
  • No patients lost more than 2 lines of best corrected vision

The following adverse events occurred in at least 1% of patients within 6 months following treatment:

Night vision difficulty 1.0%
Elevation of intraocular pressure 1.8%
Corneal Haze 2.3%
Overcorrection (became farsighted) 5.0%
Undercorrection (remained nearsighted) 5.6%
Halos around lights 9.7%
Glare 10.0%

The VISX STAR Excimer Laser System 

Low Myopia (-1.0 to -6.0 with Astigmatism <1.0 D)

The FDA approval of the VISX STAR Excimer Laser System was based in part on information obtained from 909 eyes that underwent laser vision correction as part of the clinical trials with the device. Two year follow-up data was available on 480 eyes.

The following information relates to these patients:

  • at 2 years 94% of eyes see 20/40 or better without glasses
  • at 2 years 87% of eyes see 20/25 or better without glasses
  • at 2 years 58% of eyes see 20/20 or better without glasses
  • Nearly 90% of patients treated achieved 20/40 or better vision within 1 month following surgery
  • at 2 year only 1 eye (0.3% of patients) had lost 2 lines of vision (e.g. vision decreased from a pre-operative level from 20/20 to 20/40)
  • Of the 909 eyes treated, 33 eyes (3.6%) required more than one treatment with the laser

The following adverse events occurred in at least 1% of patients following treatment:

Abnormal glare 0%
Sensitivity to bright lights 3%
Difficulty with Night Vision 4%
Double vision 1%
Elevation of intraocular pressure 2-7%
Corneal Haze 1%
Increase in astigmatism (>1 diopter) 3-5%

 

High Myopia (-6.0 to -12.0 with Astigmatism <4.0 D)

The FDA approval of the VISX STAR Excimer Laser System was based in part on information obtained from 200 eyes that underwent laser vision correction as part of the clinical trials with the device. One year follow-up data was available on 156 eyes.

The following information relates to these patients:

  • at 1 year 90% of eyes see 20/40 or better without glasses
  • at 1 year 80% of eyes see 20/30 or better without glasses
  • at 1 year 50% of eyes see 20/20 or better without glasses
  • at 1 year 4.5% of eyes with pre-treatment vision correctable to 20/20  with glasses or contact lenses had best corrected post-treatment vision worse than 20/25
  • at 1 year 1.3% of eyes with pre-treatment vision correctable to 20/20  with glasses or contact lenses had best corrected post-treatment vision worse than 20/40
  • at 1 year 9 eyes (5.8% of eyes) had lost 2 lines of vision (e.g. vision decreased from a pre-operative level from 20/20 to 20/40)
  • Of the 200 eyes treated, 3 eyes (1.5%) required more than one treatment with the laser

 

Myopic Astigmatism (-1.0 to -6.0 D with Astigmatism -0.75 to -4.5 D)

The FDA approval of the VISX STAR Excimer Laser System for myopic astigmatism was based in part on information obtained from 116 eyes that underwent laser vision correction as part of the clinical trials with the device. Follow-up data was available on 82 eyes for 24 months or longer.

The following information relates to these patients:

  • at the final visit 91.5% of eyes see 20/40 or better without glasses
  • at the final visit 81.7% of eyes see 20/30 or better without glasses
  • at the final visit 6.1% of eyes with pre-treatment vision correctable to 20/20   with glasses or contact lenses had best corrected post-treatment vision worse than 20/25
  • at the final visit 0% of eyes with pre-treatment vision correctable to 20/20  with glasses or contact lenses had best corrected post-treatment vision worse than 20/40
  • at the final visit 4 eyes (4.8% of eyes) had lost 2 lines of vision (e.g. vision decreased from a pre-operative level from 20/15 to 20/30)
  • Of the 116 eyes treated, 9 eyes (7.8%) required more than one treatment with the laser

The following adverse events were reported by patients at the final visit following treatment:

Increased difficulty with night vision 22.6%
Sensitivity to bright lights 15.5%
Worsening of symptoms of double vision 6.1%
Corneal Haze >Grade 2 1.2%
Elevation of intraocular pressure 2.4%
nidektitle.gif (1501 bytes)

The FDA approval of the Nidek EC-5000 Excimer Laser System was based in part on information obtained from 587 eyes that underwent laser vision correction as part of the clinical trials with the device. These eyes were followed for 6 months after treatment.

The following information relates to these patients:

  • at 6 months 91.3% were corrected to 20/40 or better without glasses
  • at 6 months 60.6% were corrected to 20/20 or better without glasses
  • best corrected visual acuity in 4% (-6.00 to -9.00) of the patients was worse than 20/25
  • best corrected visual acuity in 4.8% (> -10.00) of the patients was worse than 20/25

The following adverse events were reported by the patients:

Increased difficulty with night vision 48%
Increased glare 34.4%
Fluctuation of vision 48.1%
ladarvisiontitle.gif (2137 bytes)

Mild to Moderate Myopia (-1.0 to -10.0 with no astigmatism)

The FDA approval of the LadarVision Laser System was based in part on information obtained from 417 eyes that underwent laser vision correction as part of the clinical trials with the device.  These eyes were followed for 6 months after treatment.

The following information relates to these patients:

  • at 6 months 95.9% were corrected to 20/40 or better without glasses
  • at 6 months 69.7% were corrected to 20/20 or better without glasses
  • at 6 months 0.5% of patients had lost 2 lines of vision (e.g. vision decreased from a pre-operative level from 20/20 to 20/40)
  • at 6 months 0.5% of eyes with pre-treatment vision correctable to 20/20 with glasses or contact lenses had best corrected post-treatment vision worse than 20/25

The following adverse events were reported by the patients:

Feeling of something in the eye 3.0%
Double/Ghost images 2.6%
Peripheral epithelial defect 1.3%
Pain 1.3%
Halos/Starbursts 0.6%

The following complications were reported by subjects:

Difficulty with night driving 4.3%
Glare 1.7%
Halos 2.3%
Feeling of something in the eye 1.4%
Fluctuation of vision 1.1%
Blurring of vision 0.9%
Light sensitivity 0.9%
Headache 0.3%
Double vision 0.3%
Pain 0.3%
Extensive tearing 0.3%
Burning 0.3%

Mild to Moderate Myopia (-1.0 to -10.0 with up to -4.0 astigmatism)

The FDA approval of the LadarVision Excimer Laser System was based in part on information obtained from 187 eyes that underwent laser vision correction as part of the clinical trials with the device.  These eyes were followed for 6 months after treatment.

The following information relates to these patients:

  • at 6 months 93.2% were corrected to 20/40 or better without glasses
  • at 6 months 59.3% were corrected to 20/20 or better without glasses
  • No patients had lost 2 lines of vision (e.g. vision decreased from a pre-operative level from 20/20 to 20/40)
  • No patients with pre-treatment vision correctable to 20/20 with glasses or contact lenses had best corrected post-treatment vision worse than 20/25

The following adverse events were reported by the patients:

Feeling of something in the eye 2.4%
Double/Ghost images 6.2%
Peripheral epithelial defect 0.5%
Pain 1.9%
Halos/Starbursts 0.5%

The following complications were reported by subjects:

Difficulty with night driving 9.4%
Glare 4.4%
Halos 6.1%
Feeling of something in the eye 0.0%
Fluctuation of vision 3.8%
Blurring of vision 2.2%
Light sensitivity 0.5%
Headache 0.5%
Double vision 0.5%
Pain 0.0%
Extensive tearing 0.0%
Burning 0.0%

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