Transcript Rubinfeld Jan 26 - The Eye Center of Northern Colorado

CXLUSA Clinical Trial Results
S. Lance Forstot, MD, FACS
Corneal Consultants of Colorado
Founding Partner
Clinical Professor of Ophthalmology
University of Colorado
School of Medicine
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CXLUSA Clinical Trial Results
Roy S. Rubinfeld, MA, MD
Georgetown University Medical Center,
Washington Hospital Center, Washington, DC
Dr. Rubinfeld has intellectual property
in corneal strengthening technology and
financial interests in CXLO and CXLUSA
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What’s What?
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Non-commercial, physician-sponsored
UV research studies approved by IRBs since
2009. No IP, no investors
Limited number of centers
o
Commercial start up with IP, investors,
BOD, Novel Technology, Commercial
Drug, Advisors
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CXLUSA Study Group Centers
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Rubinfeld: Rockville MD, Fairfax VA
Miami FL : Center for Excellence in Eye Care
Chicago IL: Chicago Cornea Consultants, Ltd
Denver, CO: Corneal Consultants of Colorado
Los Angeles CA: LA Sight
West Hills, CA: Davidorf Eye Group
San Diego, CA: Clear View Eye and Laser Center
San Francisco, CA: Goodman Eye Center
Orange County, CA: Harvard Eye Associates
Boston, MA: Talamo Laser Eye Consultants
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CXLUSA Study Group Centers
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St. Louis, MO: Ophth Assoc- Corneal & Laser
Long Island, NY: South Shore Eye Care
Scottsdale, AZ: Schwartz Laser Eye Center
Dallas, TX: Cornea Associates of Texas
Cleveland, OH: Clear Choice Custom LASIK Center
Seattle, WA: Northwest Eye Surgeons
Spokane, WA: Empire Eye Physicians
Bloomington, MN: Minnesota Eye Consultants
Atlanta, GA: Woolfson Eye Institute
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CXLUSA Study Group Centers
 Arizona: Scottsdale
 California: Los Angeles
Orange County
San Diego
San Francisco
West Hills
 Colorado: Denver
 Florida: Miami
 Georgia: Atlanta
 Illinois: Chicago
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CXLUSA Study Group Centers
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Maryland: Rockville
Massachusetts: Boston
Minnesota: Bloomington
Missouri: St. Louis
New York: Long Island
Ohio: Cleveland
Texas: Dallas
Virginia: Fairfax
Washington: Seattle
Spokane
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CXL Mythology
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Epi-Off is Better
Epi-On is Better
Epithelium
removal is needed
to load the stroma
with riboflavin
See pictures
Transepithelial
Riboflavin Loading @12 min
15 Min Epi-On CXLO (~20 y/o pt)
Cobalt Blue Light SL Pix
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Epi-on Flare
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Epi-Off is Better
Epi-On is Better
With Epi-On CXL, the
riboflavin only
loads epithelium
which blocks the UVA
and limits CXL
See picture
15 Min Epi-On CXLO
White Light SL Pix (18 y/o Pt)
Epi-Off is Better
Epi-On is Better
Epithelium off CXL is
safer than epi-on
See pictures
Haze after Epi-Off CXL
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Delayed Epithelial Healing
and Infiltrate after Epi-Off CXL
Courtesy of W. Trattler, MD
Postop Day 2
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Postop Day 5
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Perforation after Epi-Off CXL
Epi-off Complications
o Microbial keratitis after corneal collagen crosslinking.
Perez-Santonja JCRS 2009;35(6):1138-40
o Pseudomonas keratitis after collagen crosslinking for
keratoconus: case report and review of literature. Sharma.
JCRS 2010;36(3):517-20
o Complication and failure rates after corneal crosslinking.
Koller, Seiler, et. al. JCRS 2010;36(1):185
o Permanent corneal haze after riboflavin-UVA-induced
cross-linking in keratoconus. Raiskup, Spoerl, JRS2009
Sep;25(9):S824-8.
o Corneal melting in both eyes after simultaneous corneal
cross-linking in a patient with keratoconus and Down syndrome.
Ophthalmologe. 2010 Oct; 107(10):951-5
o Corneal melting corneal collagen cross-linking for keratoconus:
A case report. Labiris. Journal of Medical Case Reports 5:15 2012
o Early ocular surface-related complications after CXL.
Gutman. Modern Medicine Sept, 2012.
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Critical Balance of 3 Reactants is Essential
Oxygen
UV light
Riboflavin
Clear Cornea- Epi-On CXL POD 1
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Epi-On Advantages
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Safety
Treat thinner, steeper, younger corneas,
Return to preop vision, function POD 1
Return to CLs in days
1 day of discomfort
 KCN as indication for PKP
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But
Epi-on is not “better”
if it doesn’t work
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Clinical Experience - Keratoconus
Vision Improvement (>= 1 line of vision)
CXLUSA vs. Hersh/Avedro
N = 177
N = 48
N = 49
N = 177
c/o William Trattler, MD
N = 48
N = 49
1 Year Results (Advanced KCN)
Formulation 1
(36 eyes)
UCVA:
Improved ≥1 Lines: 56%
Worsened: 3%
No Change: 40%
BSCVA:
Improved 1 ≥ Lines: 41%
Worsened: 32%
No Change: 24%
K Max:
Avg Flattening vs. Pre Op=
1.55D
Formulation 2
(31 eyes)
UCVA:
Improved ≥1 Lines: 64%
Worsened: 8%
No Change: 28%
BSCVA:
Improved 1≥ Lines: 56%
Worsened: 8%
No Change: 35%
K Max:
Avg Flattening vs. Pre Op=
1.41D
Epi- On CXLUSA Results
  UCVA, BSCVA by ≥ 1 line ~50%
  Kmax by ~0.7 to 1.55 D
 Tx failures <1%, 0 Adverse Events
 Comparable to Epi-Off with reduced
risk, discomfort, visual recovery time
 KCN as indication for PKP
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Limitations of CXL Alone
 Stops Progression
 Mild improvement in ~50%
 Can we do better
for advanced cases?
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Limitations of CXL Alone
 Terrific for early KCN before vision is lost
 CXL stops progression of vision loss and
corneal steepening
 For those who have lost vision from KCN
or ectasia, CXL usually yields only mild
improvement in vision and topo/tomos
 Can we do better for more adv cases?
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What if we Could Do This Consistently
With Two Non-invasive Procedures?
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Observant keratoconus patients sometimes point
out, “Pressing on my eye right here, my vision gets
much sharper.”
c/o Anita Nevyas Wallace, MD
No Finger
Pressure
20/200
Finger
Pressure at
6 o’clock
20/40
Finger
Pressure at
7 o’clock
20/30+
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CK Plus CXL Technique
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Immediately Postop CK vs Preop
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27 y/o F Caucasian w KCN @ 1 Mo
VAsc PREOP: 20/80
VAsc 1 MO PO: 20/20Preop RFx:
-2.00 +5.50 X 170 20/25
1 MO PO RFx:
pl +0.75 X 150 20/25+
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27 y/o F Caucasian w KCN @ 6 Mo
VAsc PREOP : 20/80
VAsc 6 MO PO : 20/25Preop RFx:
-2.00+5.50 X 170 20/25
6 MO PO RFx:
pl + 1.25 X 155 20/25
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CK + CXL Average UCVA OU
300
Average UCVA
250
Visual Acuity
200
# Eyes Treated
Pre-Op = 99
1 month = 71
3 months = 52
6 months = 34
12 months = 3
150
100
50
0
Pre-Op
1 month
3 months
Time
6 months
12 months
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Best Corrected Visual Acuity
CK + CXL BCSVA OU
BCSVA OU
60
50
40
30
20
10
0
Avg Pre-Op
Avg. 1 month
Avg. 3 months
Time
Avg. 6 months
Avg. 12 months
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Ongoing Data Collection
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There are known knowns;
there are things we know
that we know. There are
known unknowns; that is to
say there are things that,
we now know we don't
know. But there are also
unknown unknowns – there
are things we do not know,
we don't know. 2/12/02
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“Known Known”
 Epi-On is safer, as
effective and likely to
supplant Epi-Off
Known unknown:
 Epi-On CXL may
“lock in” CK and
become important
procedure
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Thank You
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