- 1.New Technologies for Successfully Managing Ocular Surface
Inflammation Sponsored by: Property of Bio-Tissue, Inc. Do not
reproduce or distribute
2. May be defined as Any disorder affecting the integrated
functional structures of the ocular surface 1 Accounts for
approximately 20% of visits to eye care practitioners annually2,3
Etiology/Diagnosis can be difficult due to the similarities of
various disease entities inflammation being the hallmark sign
Ocular Surface Disease 1. Pensyl CD. Preparations for dry eye and
ocular surface disease. In: Bartlett JD, Jaanus SD, eds. Clinical
ocular pharmacology, 5th ed., St. Louis: Elsevier, 2008:263-78. 2.
American Optometric Association. Care of the patient with ocular
surface disorders. St. Louis (MO): American Optometric Association;
2002 Nov. 59 p. 3. Lemp MA, Marquardt R. Introduction. In: Lemp MA,
Marquardt R, eds. The dry eye. A comprehensive guide. Berlin:
SpringerVerlag, 1992:1-2. 4.
http://www.ncbi.nlm.nih.gov/pubmed/14669026 3. Ocular Surface
Disease Infectious Bacterial Viral - HSV/HZO/EKC
Fungal/Amoebic/Parasitic Immune Severe aqueous deficiency
Filamentary keratitis Neurotrophic keratitis Chronic allergic
(vernal) keratoconjunctivitis Limbal stem cell deficiency
Traumatic/Systemic Corneal abrasion PED Exposure TED, injury, palsy
Recurrent corneal erosion Chemical burn Iatrogenic Stevens-Johnson
syndrome Post cataract / DSEK / Bplasty Cl induced LSC deficiency
4. Treat Underlying Pathology Address Inflammation Await Healing
Current Treatment Paradigm Passive Therapies to Reduce
Inflammation: Bandage Contact Lens o Pro: Mechanical barrier to
external irritants, helps with pain o Con: Potential to induce
infection Topical MedicationsSteroids/NSAIDs o Pro: Reduce
inflammation, helps with pain o Con: Delay healing and increase
potential for infection 5. Emerging Treatment Paradigm Treat
Underlying Pathology CONTROL INFLAMMATION Prevent Progressive
Tissue Damage Stimulate REGENERATIVE HEALING Key to minimizing a
sight-threatening scar is limiting inflammatory response and
promoting healing 6. Amniotic membrane is the innermost lining of
the placenta and shares the same cell origin as the fetus Amniotic
membrane biologic therapy: o Promotes regenerative healing o
Reduces inflammation o Minimizes scar formation o Inhibits
angiogenesis o Minimizes pain Amniotic Membrane: An Emerging
Clinical Option 7. Extracellular matrix (ECM) components promote
regenerative tissue processes1,2,3 Key components Heavy chain
hyaluronic acid Proteoglycans Growth factors Collagens (types I,
III, IV, V and VI) Fibronectin Laminin, MMP inhibitors Key Amniotic
Membrane Components 1. Rinastiti M, et al. Int J Oral Maxillofac
Surg. 2006;35:247-251. 2. Jin CZ, et al. Tissue Eng.
2007;13:693-702. 3. Niknejad H, et al. Eur Cell Mater.
2008;15:88-99. 4. He H, et al. J Biol Chem. 2009;284:20136-20146.
5. Data on file, Bio-Tissue, Inc., 2012. 6. Hopkinson A, et al.
Invest Ophthalmol Vis Sci. 2006;47:4316-4322. Direct inhibition of
pro-inflammatory cells 4,5 Suppresses T-cell activation
Dose-dependently inhibits giant cell formation Biological
scaffolding Regenerative healing 6 8. Bio-Tissue Cryopreservation
method ensures retention of key active components of the
Extracellular Matrix to promote healing and integrity of tissue
structure Cryopreserved Amniotic Membrane is safe and effective o
Extensive number of peer reviewed articles / publications o
Bio-Tissue Cryopreserved Amniotic Membrane is the only Amniotic
Membrane granted wound healing indication by the FDA Available as
Amniograft (typically thick, multilayered, sutured or glued) and
Prokera (self retaining) Why Cryopreservation vs dry? 1. Rinastiti
M, et al. Int J Oral Maxillofac Surg. 2006;35:247-251. 2. Jin CZ,
et al. Tissue Eng. 2007;13:693-702. 3. Niknejad H, et al. Eur Cell
Mater. 2008;15:88-99. 9. Product Specifications Outer Ring
Diameter: 21.6 mm 21.6 mm 21.6 mm Inner Ring Diameter: 17.9 mm 15.5
mm 15.5 mm Device Height 0.7 mm 1.1 mm 1.1 mm Tissue Thickness
Single Layer Single Layer Multiple Layers Ring Description Ring
& Elastomeric Band System (polycarbonate) Dual Ring System
(polycarbonate) Dual Ring System (polycarbonate) 10. Band
keratopathy Post PRK/PTK haze Chemical burns Corneal epithelial
defects- RCE, EBMD Corneal ulcers, acute and non-healing
Superficial keratectomy/debridement for Saltzmanns, bullous
keratopathy post DSEK Keratitis - k. sicca, infectious, exposure,
filamentary, LCSD, neurotrophic PED (DM, aging, post HSV, post sx)
Pterygium sx, conjunctival tumor resection Stevens-Johnson Syndrome
CONFIDENTIAL AND PRIVILEGED Property of Bio-Tissue, Inc.. Do not
reproduce or distribute. Indications Overview 11. 52 year-old
female presented with ocular pain and blurred vision (20/200) for 2
weeks. She had a history of similar attacks & diagnosed as RCE.
Epithelial debridement, lubricants and BCL failed to relieve pain
and halt recurrence. Treatment Strategy Epithelial debridement to
remove loose epithelium (Fig. A, B) followed by placement of
PROKERA SLIM Complete healing within 3 days, resulting in clear
cornea and 20/20 vision. A smooth surface remained stable with no
recurrence for 13 months follow-up Recurrent Corneal Erosion 12. 61
year-old female with long history of severe dry eye and exposure
keratopathy (OD>OS) due to incomplete blinking and lagophthalmos
(blepharoplasty). No response to (Restasis), copious NPATs and
punctal plugs. Treatment Strategy PROKERA SLIM was inserted OD for
one week After removal of PROKERA SLIM o Patient comfortable o The
eye was quiet, with a crystal clear cornea Dry Eye with Exposure
13. PROKERA Treatment Tips Insert only after rinsing well with
saline or CL solution and installation of topical anesthetic
PROKERA SLIM most common Topical medications may be used while in
place Temporary Tarsorrhaphy (PRN) o TransporeTape o Nasal Strips
Follow-up within 3-7 days (10 day global period) During the healing
process the membrane will thin or dissolve time dependent based on
inflammation Easily removed in the office once the healing is
completed use topical anesthetic and blunt forceps 14. Not for
severe LSC loss May need repeated applications Not indicated for
major structural damage, tissue loss or deep stromal defects.
Amniograft or dry AM (Ambiodry) surgical placement more effective
for perforations and deep wounds PROKERA limitations 15. Code
65778, most insurers include materials and pay $1250-1600 Prokera
cost $800-900 net $400-800 Include materials code v2790 (with
invoice) and may also get paid from commercial carriers for
materials net $1200-1600 Can bill multiple times as clinically
indicated CONFIDENTIAL AND PRIVILEGED Property of Bio-Tissue, Inc..
Do not reproduce or distribute. Billing 16. Same day billing with
other procedures: Bill as primary procedure, use -59 modifier for
others and see lower reimbursements Next day or subsequent billing
, staged procedures, within global period 58 mod If unrelated to a
prior procedure (DSEK, PTK, cataract) but within global period, -79
mod Can be repeated as needed 10 day global CONFIDENTIAL AND
PRIVILEGED Property of Bio-Tissue, Inc.. Do not reproduce or
distribute. Billing 17. Managing Demodex Blepharitis and
Keratoconjunctivitis 18. Demodex Mites1,2 An Often Overlooked Link
to Blepharitis Demodex blepharitis is the most common but often
overlooked external disease problem, causing ocular surface
inflammation Ocular Demodex infestation has been difficult to
eradicate Demodex can exacerbate many other conditions such as dry
eye, MGD, pterygium and rosacea 1. Rufli et al (1981)
dermatologica; 162: 1-11 2. Liu et al (2010) Curr Opin Allergy Clin
Immunol; 10:505-10 Demodex BrevisDemodex Folliculorum 19. OD
(Normal Eye) OS (Demodicosis)(Same Patient) Structural damage due
to mites digesting and destroying the Meibomian glands.
Meibography: MGD Linked to Demodex 20. 1. Coston, 1967, English,
1971, English & Nutting, 1981, Heacock,1986, Fulk &
Clifford, 1990, 2. Fulk et al, 1996, Kamoun et al. 1999, Morfin,
2003 Skin Manifestation Demodex has been linked to rosacea,
pityriasis folliculorum, perioral dermatitis, pustular
folliculitis, and basal cell carcinoma.1,2 21. 1. Coston 1967; Gao
et al, IOVS 46:3089, 2005 Diffuse CD Sporadic CD CleanGreasy Scales
Cylindrical dandruff (CD) is diagnostic for Demodex, but its
absence does not denote a negative diagnosis1 Eyelash manifestation
Trichiasis, malalignment, madarosis Lash epilation may be necessary
to confirm dx Supplies Forceps Microscope Diagnosing Demodex 22.
Approach Targets Warm compresses Oil glands Baby shampoo lid scrubs
Lid margin, lashes Commercial lid scrubs Lid margin, lashes Topical
antibiotic Microbes Omega-3 fatty acids Inflammation, oil glands
Oral Tetracycline/Doxycycline Inflammation, oil glands Past
Approaches to Blepharitis and Lid Margin Diseases 23. Studies
Report that TTO Lid Scrub Helps Manage Cylindrical Dandruff and
Conj. Inflammation1 Before After 1. Kheirkhah et al, AJO, 143:743,
2007 24. Authors: Sean Tighe, Ying-Ying Gao, Scheffer C. G. Tseng
Published in: Translational Vision Science & Technology
Journal, 2013 Purpose: To determine the active ingredient in tea
tree oil (TTO) responsible for its reported killing effect on
Demodex mites Method: Using an in vitro killing assay screened
concentrations of 13 out of the 15 known ingredients of TTO
Results: 4-Terpineol 1. Was the most potent ingredient to exhibit
killing effects 2. Was more potent than TTO at equivalent
concentrations 3. Was effective in killing mites at a concentration
of 1% 4-Terpinenol is the Most Active Ingredient of Tea Tree Oil
(TTO) to Kill Demodex Mites 1. Tighe Sean, et al, Terpinen-4-ol is
the Most Active Ingredient of Tea Tree Oil to Kill Demodex Mites,
Translational Vision Science and Technology, August 2013, Vol. 2,
No. 7 25. Allergic reactions were observed when TTO was used as a
topical formulation1 Oxidation products formed during prolonged
storage of TTO generate -cymene (an ineffective ingredient), as
well as peroxides and epoxides1 Some of these TTO ingredients
relationships are clinically antagonistic Why is 4-Terpineol
Isolation Important 1. Carson, C.F., et al, Melaleuca alternifolia
(Tea Tree) Oil: a Review of Antimicrobial and Other Medicinal
Properties, Clinical Microbiology Reviews, Jan. 2006, p50-62 Vol.
19, No.1 2. Tighe Sean, et al, Terpinen-4-ol is the Most Active
Ingredient of Tea Tree Oil to Kill Demodex Mites, Translational
Vision Science and Technology, August 2013, Vol. 2, No. 7 26.
Beyond Tea Tree Oil Cliradex contains 4-Terpineol without
preservatives for allergy and toxin-free treatment Indicated for
lids, lashes and face Useful for Demodex and rosacea associated
blepharitis and keratoconjunctivitis, MGD and peri- ocular
dermatitis 1. Tighe Sean, et al, Terpinen-4-ol is the Most Active
Ingredient of Tea Tree Oil to Kill Demodex Mites, Translational
Vision Science and Technology, August 2013, Vol. 2, No. 7 27.
Male,17 Cylindrical dandruff, redness, irritation in OS for 6
months Didnt respond well to antibiotics and steroids Signs &
symptoms subsided dramatically after 10 days of Cliradex use. No
recurrence during 3 months follow up Case Study OS Before OS After
28. Before & After Cliradex Use Before Before After 6 weeks 29.
Rx towelette use qd to bid for 4-6 wks, 2 cartons typically rxd
Place lightly over closed eyelid and rub side to side for 10-15
seconds, then wait one minute before opening Repeat for fellow eye
Can use separate wipe for facial rosacea Follow-up in 4-6 wks
Rarely needs re-treatment, but may rx a maintenance program as
needed Components: Water 4-Terpineol Glycerin Polysorbate 20
Polysorbate 80 Carbomer Triethanolamine Patient instructions 30.
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