Post on 14-Dec-2015
Conductive Keratoplasty for Conductive Keratoplasty for the Correction of Low to the Correction of Low to
Moderate Hyperopia:Moderate Hyperopia:
U.S. Clinical Trial U.S. Clinical Trial 12-Month Results12-Month Results
U.S. Clinical InvestigatorsU.S. Clinical Investigators
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
Marguerite McDonald, MD – Medical Monitor
• Treats hyperopia, astigmatism, presbyopia and over/under LASIK corrections
• Induces permanent collagen shrinkage
• Creates a column of treatment
• Utilizes cornea’s conductive properties
Conductive Keratoplasty FeaturesConductive Keratoplasty Features
The Keratoplast™ tip (90 µm wide, 450 µm The Keratoplast™ tip (90 µm wide, 450 µm long) long)
with coated stop at the distal endwith coated stop at the distal end
(shown next to a 7-0 suture)(shown next to a 7-0 suture)
• 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
Study ObjectiveStudy Objective
DemographicsDemographics
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
Simple ProcedureSimple Procedure
• Instill topical anesthesia
• Insert lid speculum (return path for energy)
• Mark eye
• Apply treatment
Total time less than 5 minutes
6 mm OZ
Number, Location, and Sequence of Number, Location, and Sequence of Treatment SpotsTreatment Spots
Sequence
26
4
7
3
51
8
8 mm OZ7 mm OZ32 spots
(2.375 to 3.00 D)24 spots
(1.75 to 2.25 D)
16 spots(1.00 to 1.625 D)
8 spots(0.75 to 0.875 D)
Postoperative UCVA Over TimePostoperative UCVA Over Time
404550
566364
737586
9093 92
0102030405060708090
100
Per
cen
t
20/20 or > 20/25 or > 20/40 or >
Month 3 N=358
Month 6N=352
Month 9N=347
Month 12N=318
Accuracy of Achieved RefractionAccuracy of Achieved Refraction
56 61 64 63
8388 87 89
9799 99 99
0102030405060708090
100
Per
cen
t
+/- 0.5 D +/- 1.0 D +/- 2.0 D
Month 3N=358
Month 6N=352
Month 9N=347Month 12N=318
MRSE Stability through 12 MonthsMRSE Stability through 12 MonthsPatients with Consecutive VisitsPatients with Consecutive Visits
74
8793
83
96 9889
98 99
0102030405060708090
100
Per
cent
3 to 6 Mo. 6 to 9 Mo. 9 to 12 Mo.
<0.50 D<0.75 D<1.00 D
Mean Change 0.25 D (0.50) 0.11 D (0.41) 0.11 D (0.35)in MRSEConf. Interval 0.19, 0.31 0.07, 0.15 0.07, 0.15
Safety VariablesSafety Variables
12 Months
N=383
2 lines lost BSCVA 2%
> 2 lines lost BSCVA 0.0%
BSCVA Worse than 20/40 0.0%
Increase >2.00 D Cylinder 0.3%
Pre-Op 20/20, Post-op 20/25 0.0%
Induced Cylinder >2.00 D Induced Cylinder >2.00 D CK vs. Non-Contact LTKCK 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.
Summary Efficacy VariablesSummary Efficacy Variables
FDA
Guideline
6 Mos.
(N = 352)
12 Mos.
(N = 318)
UCVA < 20/20 50% 45% 56%
UCVA < 20/25 Not Stipulated 64% 75%
UCVA < 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.
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
• 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
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
Conductive Keratoplasty: Conductive Keratoplasty: Case StudyCase 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
Conductive KeratoplastyConductive Keratoplasty: : Case StudyCase Study
Conductive KeratoplastyConductive Keratoplasty: : Case StudyCase 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
Confocal View Of CKConfocal View Of CKFolds Between Treatment SpotsFolds Between Treatment Spots
Sabry, McDonald, Klyce - 2001
Confocal View Of CKConfocal View Of CKDeep CK Treatment With Healthy EndotheliumDeep CK Treatment With Healthy Endothelium
Sabry, McDonald & Klyce - 2001
Summary of Phase III StudySummary of Phase III Study
• Highly effective Highly effective – comparable to H-LASIKcomparable to H-LASIK
• Stability at 6 months Stability at 6 months
• Safe – low rate induced cylinder Safe – low rate induced cylinder
• Penetration depth confirmed by Penetration depth confirmed by histology, confocal microscopyhistology, confocal microscopy
Summary of Phase III StudySummary of Phase III Study
• Topography shows central corneal Topography shows central corneal steepening with mid-peripheral steepening with mid-peripheral flattening flattening
• Visual axis sparedVisual axis spared
• Multicenter study continues for two Multicenter study continues for two yearsyears