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U.S. Clinical Investigators

Conductive Keratoplasty for the Correction of Low to Moderate Hyperopia: U.S. Clinical Trial 12-Month Results. Vera Kowal, MD Richard Lindstrom, MD Robert Maloney, MD Edward Manche, MD Roger Meyer, MD Thomas Samuleson, MD Timothy Schneider, MD Kaz Soong, MD Alan Sugar, MD.

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U.S. Clinical Investigators

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  1. Conductive Keratoplasty for the Correction of Low to Moderate Hyperopia:U.S. Clinical Trial 12-Month Results

  2. Vera Kowal, MD Richard Lindstrom, MD Robert Maloney, MD Edward Manche, MD Roger Meyer, MD Thomas Samuleson, MD Timothy Schneider, MD Kaz Soong, MD Alan Sugar, MD U.S. Clinical Investigators Marguerite McDonald, MD – Medical Monitor • Penny Asbell, MD • Stephen Brint, MD • William Culbertson, MD • Jonathan Davidorf, MD • Elizabeth Davis, MD • Dan Durrie, MD • R. Bruce Grene, MD • Peter Hersh, MD • David Hardten, MD

  3. Conductive Keratoplasty Features • Treats hyperopia, astigmatism, presbyopia and over/under LASIK corrections • Induces permanent collagen shrinkage • Creates a column of treatment • Utilizes cornea’s conductive properties

  4. ViewPoint™ CK System

  5. The Keratoplast™ tip (90 µm wide, 450 µm long) with coated stop at the distal end(shown next to a 7-0 suture)

  6. Conductive Keratoplasty (CK)

  7. Study Objective • US FDA Phase III Study • 400 Patients • Spherical hyperopia 0.75 D to 3.00 D • < 0.75 D of cylinder • No prior refractive surgery • No significant ocular/physical history • 24 Month Follow-Up

  8. Demographics

  9. Simple Procedure • Instill topical anesthesia • Insert lid speculum (return path for energy) • Mark eye • Apply treatment Total time less than 5 minutes

  10. Conductive Keratoplasty (CK)

  11. Number, Location, and Sequence of Treatment Spots Sequence 8 spots (0.75 to 0.875 D) 16 spots (1.00 to 1.625 D) 1 5 8 3 4 6 7 2 6 mm OZ 32 spots (2.375 to 3.00 D) 24 spots (1.75 to 2.25 D) 7 mm OZ 8 mm OZ

  12. Slit Lamp Photo 1 Hour After CK Small leucoma Visible striae

  13. Postoperative UCVA Over Time

  14. Accuracy of Achieved Refraction

  15. MRSE Stability through 12 MonthsPatients with Consecutive Visits Mean Change 0.25 D (0.50) 0.11 D (0.41) 0.11 D (0.35) in MRSE Conf. Interval 0.19, 0.31 0.07, 0.15 0.07, 0.15

  16. Safety Variables

  17. Induced Cylinder >2.00 D CK vs. Non-Contact LTK 1Sunrise LTK FDA Clinical Study, 2Conductive Keratoplasty 12-Month FDA Clinical Study Results.

  18. Summary Efficacy Variables Data from patients with single treatment. No retreatments included.

  19. Preoperative 50 year old Female African American Good health No ocular history 6 mm pachymetry: 556 µm IOP: 15 mm Hg Preoperative UCVAD: 20/125 UCVAN: J12 Manifest RX: + 3.25 – 0.75 X 130 Cycloplegic RX: + 3.25 – 0.25 X 130 BSCVAD: 20/25 Conductive Keratoplasty: Case Study

  20. Conductive Keratoplasty: Case Study • Operative • Instilled three drops topical anesthesia • Inserted lid speculum • Applied 32 treatment spots • Removed lid speculum • Instilled NSAID and antibiotic • Immediate K-Readings: • 51.75 @ 180 X 49.62 @90

  21. Conductive Keratoplasty: Case Study • 1 Day Post-Operative • UCVAD: 20/32 • UCVAN: J7 • Manifest RX: + 1.50 – 0.50 X 120 • BSCVAD: 20/20 • BSCVAN: J2 • Slit Lamp: small epithelial defects

  22. Conductive Keratoplasty: Case Study • 1 Month Post-Operative • UCVAD: 20/20 • UCVAN: J2 • Manifest RX: - 0.25 – 0.75 X 125 • BSCVAD: 20/20 • BSCVAN: J1 • Slit Lamp Exam: WNL

  23. Conductive Keratoplasty: Case Study • 3 Month Post-Operative • UCVAD: 20/32 • UCVAN: J2 • Manifest RX: plano – 1.00 X 125 • BSCVAD: 20/16 • BSCVAN: J1 • Slit Lamp Exam: WNL

  24. 6 Month Post-Operative UCVAD: 20/30 UCVAN: J2 Manifest RX: + 0.25 – 0.75 X 125 BSCVAD: 20/25 BSCVAN: J1 Slit Lamp Exam: WNL Conductive Keratoplasty: Case Study

  25. 12 Month Post-Operative UCVAD: 20/20 UCVAN: J2 Manifest RX: + 0.25 – 0.25 X 110 BSCVAD: 20/16 BSCVAN: J1 Slit Lamp Exam: WNL Conductive Keratoplasty: Case Study

  26. Preoperative 50 year old Female UCVAD: 20/125 UCVAN: J12 Manifest RX: + 3.25 – 0.75 X 130 BSCVAD: 20/25 12 Months Post-op UCVAD: 20/20 UCVAN: J2 Manifest RX: + 0.25 – 0.25 X 110 BSCVAD: 20/16 Conductive Keratoplasty: Case Study No retreatment. Spherical correction only

  27. Corneal Topography: Case Study 12 month Post-op Preoperative

  28. Confocal View Of CKFolds Between Treatment Spots Sabry, McDonald, Klyce - 2001

  29. Confocal View Of CKDeep CK Treatment With Healthy Endothelium Sabry, McDonald & Klyce - 2001

  30. Cylindrical Footprint of CK

  31. Summary of Phase III Study • Highly effective • comparable to H-LASIK • Stability at 6 months • Safe – low rate induced cylinder • Penetration depth confirmed by histology, confocal microscopy

  32. Summary of Phase III Study • Topography shows central corneal steepening with mid-peripheral flattening • Visual axis spared • Multicenter study continues for two years

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