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

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

• 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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Conductive Keratoplasty Features

• Treats hyperopia, astigmatism, presbyopia and
  over/under LASIK corrections
• Induces permanent collagen shrinkage
• Creates a column of treatment
• Utilizes corneas conductive properties

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ViewPoint CK System
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The Keratoplast tip (90 µm wide, 450 µm long)
with coated stop at the distal end(shown next
to a 7-0 suture)
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Conductive Keratoplasty (CK)
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Study Objective

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

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Demographics
Number of Patients Number of Eyes 233 401
Mean Age Range 55 /- 5.4 years (40 to 74)
Mean Preoperative MRSE Median MRSE 1.82 /- 0.60 D 1.75 D
Mean Preoperative CRSE 1.86 /- 0.63 D
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Simple Procedure

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

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Conductive Keratoplasty (CK)
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Number, Location, and Sequence of Treatment Spots
Sequence
16 spots (1.00 to 1.625 D)
8 spots (0.75 to 0.875 D)
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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
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Slit Lamp Photo 1 Hour After CK
Small leucoma
Visible striae
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Postoperative UCVA Over Time
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Accuracy of Achieved Refraction
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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
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Safety Variables
12 Months N383
? 2 lines lost BSCVA 2
? gt 2 lines lost BSCVA 0.0
? BSCVA Worse than 20/40 0.0
? Increase gt2.00 D Cylinder 0.3
? Pre-Op ?20/20, Post-op ?20/25 0.0
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Induced Cylinder gt2.00 D CK vs. Non-Contact LTK
Post-op Month LTK1 CK2
1 Month 3.4 3.0
3 Months 1.4 2.0
6 Months 0.9 1.0
12 Months 0.2 0.3
1Sunrise LTK FDA Clinical Study, 2Conductive
Keratoplasty 12-Month FDA Clinical Study Results.
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Summary Efficacy Variables
FDA Guideline 6 Mos. (N 352) 12 Mos. (N 318)
UCVA lt 20/20 50 45 56
UCVA lt 20/25 Not Stipulated 64 75
UCVA lt 20/40 85 90 92
MRSE 0.50 50 61 63
MRSE 1.00 75 88 89
Data from patients with single treatment. No
retreatments included.
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Conductive Keratoplasty Case Study

• 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

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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 _at_ 180 X 49.62 _at_90

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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

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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

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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

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Conductive Keratoplasty Case Study

• 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

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Conductive Keratoplasty Case Study

• 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

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Conductive Keratoplasty Case Study

• 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

No retreatment. Spherical correction only
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Corneal Topography Case Study
12 month Post-op
Preoperative
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Confocal View Of CKFolds Between Treatment Spots
Sabry, McDonald, Klyce - 2001
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Confocal View Of CKDeep CK Treatment With
Healthy Endothelium
Sabry, McDonald Klyce - 2001
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Cylindrical Footprint of CK
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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

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Summary of Phase III Study

• Topography shows central corneal steepening with
  mid-peripheral flattening
• Visual axis spared
• Multicenter study continues for two years