Presbia PLC

Presbia — Technical Presentation (May 2016)

14 slides from Presbia's technical presentation, May 2016

  1. Slide 1: Decentration Effect on Presbia Microlens

    Decentration Effect on Presbia Microlens Acuity endpoint analysis ISOP Copenhagen 2016 Wayne Crewe-Brown, MD Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  2. Slide 2: Overview

    Overview  Purpose  Determine effect on visual acuity of degrees of decentration from visual axis  Study Design  Retrospective observational analysis  Method  Deviation from ideal centration of the Presbia Microlens measured on the iTrace Ray Tracing aberometer (www.traceytechnologies.com)  Co

  3. Slide 3: Demographics

    Demographics  122 patients with Presbia Microlens implanted in non- dominant eye in a commercial laser refractive clinic  Male: 59 Female: 63  Emmetropic Presbyopes: 51  Concurrent LASIK procedure: 69 Caution: Investigational Device. Limited by Federal (or United States) law to investigational u

  4. Slide 4: Presbia Microlens

    Presbia Microlens  Hydrophilic polymer material  Implanted in the cornea  0.5mm hole in the center of the disc that permits the transfer of oxygen and nutrients† †Larrea X, De Courten C, Feingold V, Burger J, Büchler P. Oxygen and glucose distribution after intracorneal lens implantation. Optom V

  5. Slide 5: Ideal Implantation Position

    Ideal Implantation Position  Presbia Microlens is placed in a corneal stomal pocket  300um from the epithelium  Centered on the 1st Purkinje  Patient fixating on target on Laser platform (here the Visx S4 IR, AMO)  1st Purkinje reflex viewed through coaxial microscope Caution: Investigational D

  6. Slide 6: iTrace Centration

    iTrace Centration Presbia Microlens in-situ iTrace measurements Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  7. Slide 7: Key Endpoints

    Key Endpoints • UCDVA: Uncorrected Distance acuity • BCDVA: Best corrected Distance acuity • UCNA: Uncorrected Near acuity • Decentration from visual axis (P1) in microns Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  8. Slide 8: Acuities Summary

    Acuities Summary Means (logMAR) Wilcox Ranked Sum Paired pValues UCDVA BCDVA UCNVA UCDVA BCDVA UCNVA 1m vs. 3m 0.262 0.112 0.429 PreOp 0.205 -0.054 0.777 Column1 UCDVA BCDVA UCNVA 1 Month 0.450 0.208 0.402 LASIK vs. Pocket 0.139 0.638 0.798 3 Month 0.420 0.164 0.378 only Paired Wilcox Ranked sum tes

  9. Slide 9: Methodology

    Methodology  Statistical analysis of the acuity outcomes for all three endpoints revealed no significant difference between the 1 and 3 month intervals  Accordingly the 3 month outcomes were used for post-op correlation to decentration  Decentration was measured on the iTrace unit  Decentration

  10. Slide 10: Acuities by Decentration

    Acuities by Decentration Categories: • A= less than 100um • B= 100-200um • C= 200-300um • D= 300-400um • E= 400-500um • F= 500+ Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  11. Slide 11: Multiple Regression Plots

    Multiple Regression Plots • Acuity endpoints vs. decentration group • All 3 Regression lines flat or negative Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.

  12. Slide 12: Correlation Tests

    Correlation Tests UCDVA BCDVA UCNVA p.value 0.836 0.0683 0.741 UCDVA BCDVA UCNVA rho 0.021 -0.196 0.034 • Spearman Rho Correlation (multiple regression analysis) shows no statistical significance (p>0.05) in all endpoints • Indicating no correlation between magnitude of decentration and acuity endpo

  13. Slide 13: Discussion

    Discussion  The lack of correlation between the acuity endpoints at both distance and near to decentration is surprising  Possible reasons for this presentation are the skew of the decentration values towards the lower magnitudes.  The source of the data too, needs consideration. All outcomes wer

  14. Slide 14: Summary

    Summary  From this review it appears the Presbia Microlens is not overly sensitive to small errors in centration  The variability and range of outcomes presented in a commercial setting likely explained by:  Patient adaptive factors  20/Happy refraction culture in commercial setting  A more con

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