ARTIFLEX PIOL for the Correction of Myopia in Phakic Eyes:

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ARTIFLEX PIOL for the Correction of Myopia in
Phakic Eyes Jan Venter MD Optimax, laser eye
specialists London, UK

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Introduction Study Design Demographics Results Pre
liminary Observations
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ARTIFLEX PIOL
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ARTIFLEX Instruments
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Introduction Study Design Demographics Results Pre
liminary Observations
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ARTIFLEX Myopia Clinical Study
Study objective To determine the safety and
efficacy of the ARTIFLEX PIOL
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ARTIFLEX Myopia Clinical Study
Study design

• 31 eyes (min follow up 6 months)
• Follow-up at 1 day postop
• 1 week postop
• 3 months postop
• 6 months postop
• 12 months postop

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ARTIFLEX Myopia Clinical Study
Patient selection criteria

• Correction of myopia from 2.0 D to 12.0 D
• ACD gt 3.2 mm
• Preoperative Endothelial Cell Count gt 2000 c/mm2
• Normal-light pupil size lt 6mm
• 18 years to 60 years old
• lt 2.5 D of cylinder
• Stable Refraction (lt0.5 D, 3 months)
• No confounding preoperative pathology

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Introduction Study Design Demographics Results Pre
liminary Observations
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Demographics
Age
N 31 Mean 31 yrs Std
9.5 Range 18 - 51
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Demographics
Gender
Eye
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Surgery
Incision Size
Mean incision size 3.2mm Corneal incision in
100 of cases Topical
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Introduction Study Design Demographics Results Pre
liminary Observations
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Safety Analysis Change in BSCVA
6 months 31 eyes
41 gained 1 line or more
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Efficacy Analysis UCVA Postop
1,0 or better - 81 of eyes 0,5 or better -
97 of eyes
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Efficacy Analysis Efficacy
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Predictability of Refraction Intended vs Achieved
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Refractive outcome
81 of eyes within 0.5 D 94 of eyes within
1.0 D
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Stability of Refraction
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Complications
Iritis 1 case Pigment Precipitates 0
cases Glare 0 cases Halos 1 cases
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Conclusion

• The predictability, efficacy and safety were
  excellent in all 31 eyes implanted with Artiflex
  lenses
• Less surgery time
• Fast visual recovery, similar to LASIK
• Less complications than Artisan

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B. Christiaans
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Thank you