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

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

ViewPointViewPoint™™ CK System CK System

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)

Conductive Keratoplasty (CK)Conductive Keratoplasty (CK)

• 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

Conductive Keratoplasty (CK)Conductive Keratoplasty (CK)

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)

Slit Lamp Photo 1 Hour After CKSlit Lamp Photo 1 Hour After CK

Small leucoma

Visible striae

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

Corneal Topography: Case StudyCorneal Topography: Case Study

Preoperative 12 month Post-op

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

Cylindrical Footprint of CKCylindrical Footprint of CK

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