®copyright rubinfeld 2013 cxlusa clinical trial results s. lance forstot, md, facs corneal...

®Copyright Rubinfeld 2013Copyright Rubinfeld 2013

CXLUSA Clinical Trial Results

S. Lance Forstot, MD, FACSCorneal Consultants of Colorado

Founding Partner

Clinical Professor of Ophthalmology

University of Colorado

School of Medicine


CXLUSA Clinical Trial Results

Roy S. Rubinfeld, MA, MD Georgetown University Medical Center,

Washington Hospital Center, Washington, DC

Dr. Rubinfeld has intellectual property Dr. Rubinfeld has intellectual property in corneal strengthening technology and in corneal strengthening technology and

financial interests in CXLO and CXLUSA financial interests in CXLO and CXLUSA


o 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

What’s What?


CXLUSA Study Group Centers


CXL Mythology

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


Epi-on Flare


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)


Epithelium off CXL is safer than epi-on

See pictures


Haze after Epi-Off CXL


Delayed Epithelial Healing and Infiltrate after Epi-Off CXL

Postop Day 2Postop Day 2

Courtesy of W. Trattler, MD Courtesy of W. Trattler, MD

®Copyright Rubinfeld 2013Copyright Rubinfeld 2013Postop Day 5Postop Day 5

Perforation after Epi-Off CXL


Epi-off Complications

o Microbial keratitis after corneal collagen crosslinking. Perez-Santonja JCRS 2009;35(6):1138-40o Pseudomonas keratitis after collagen crosslinking for

keratoconus: case report and review of literature. Sharma. JCRS 2010;36(3):517-20o Complication and failure rates after corneal crosslinking.

Koller, Seiler, et. al. JCRS 2010;36(1):185o 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.

Critical Balance of 3 Reactants is Essential

Riboflavin

UV light Oxygen


Clear Cornea- Epi-On CXL POD 1


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

Epi-On Advantages


Epi-on is not “better” if it doesn’t work

But

Clinical Experience - Keratoconus

c/o William Trattler, MD

Vision Improvement (>= 1 line of vision) CXLUSA vs. Hersh/Avedro

N = 177 N = 48 N = 49 N = 48N = 177 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


Stops ProgressionMild improvement in ~50% Can we do better

for advanced cases?

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?

Limitations of CXL Alone


What if we Could Do This Consistently With Two Non-invasive Procedures?


No Finger Pressure

Finger Pressure at

6 o’clock20/200 20/40

Finger Pressure at

7 o’clock20/30+

Observant keratoconus patients sometimes point out, “Pressing on my eye right here, my vision gets

much sharper.”

c/o Anita Nevyas Wallace, MD


CK Plus CXL Technique


Immediately Postop CK vs Preop


27 y/o F Caucasian w KCN @ 1 MoVAsc PREOP: 20/80 VAsc 1 MO PO: 20/20- Preop RFx:

-2.00 +5.50 X 170 20/25

1 MO PO RFx: pl +0.75 X 150 20/25+


27 y/o F Caucasian w KCN @ 6 Mo

VAsc PREOP : 20/80 VAsc 6 MO PO : 20/25- Preop RFx: -2.00+5.50 X 170 20/25 6 MO PO RFx: pl + 1.25 X 155 20/25


Ongoing Data Collection


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


“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


Thank You

®copyright rubinfeld 2013 cxlusa clinical trial results s. lance forstot, md, facs corneal...

Documents

copyright rubinfeld

cxlusa slide

cxl slide

md slide

picture slide

flare slide

cxl mythology slide

yo pt slide