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4/13/17 1 Advancements in Therapeutic Surgical Options for the Cornea Mitch Ibach, OD Vance Thompson Vision no relevant financial disclosures The cornea is assisted by a tear film and is composed of five layers. Corneal conditions commonly corrected by surgery Corneal Surgery Anatomical Timeline • Penetrating Keratoplasty (PKP) • Deep Anterior Lamellar Keratoplasty • Descemet’s Stripping Endothelial Keratoplasty • Descemet’s Membrane Endotheial Keratoplasty Corneal Grafts are increasing in number Registry study of total # corneal grafts per year from 2000-2012 Coster, D. J., Lowe, M. T., Keane, M. C., & Williams, K. A. (2015, May). A Comparison of Lamellar and Penetrating Keratoplasty Outcomes. American Academy of Ophthalmology, 121(5), 979-987. 0 200 400 600 800 1000 1200 1400 1600 2000 2008 2012 Number of grafts Year Anterior Lamellar grafts Endothelial grafts Penetrating grafts Lambert, L. (Artist). Clienteles Cartoons 5 of 16. [Painting]. Cartoon Stock.

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4/13/17

1

Advancements in Therapeutic Surgical

Options for the CorneaMitch Ibach, OD

Vance Thompson Vision

no relevant financial disclosures

The cornea is assisted by a tear film and is composed of five layers.

Corneal conditions commonly corrected by surgery

Corneal Surgery Anatomical Timeline

• Penetrating Keratoplasty (PKP) • Deep

Anterior Lamellar Keratoplasty

• Descemet’s Stripping Endothelial Keratoplasty

• Descemet’s Membrane Endotheial Keratoplasty

Corneal Grafts are increasing in number

• Registry study of total # corneal grafts per year from 2000-2012

Coster, D. J., Lowe, M. T., Keane, M. C., & Williams, K. A. (2015, May). A Comparison of Lamellar and Penetrating Keratoplasty Outcomes. American Academy of Ophthalmology, 121(5), 979-987.

0

200

400

600

800

1000

1200

1400

1600

2000 2008 2012

Num

ber

of g

raft

s

Year

Anterior Lamellar grafts

Endothelial grafts

Penetrating grafts

Lambert, L. (Artist). Clienteles Cartoons 5 of 16. [Painting]. Cartoon Stock.

4/13/17

2

Here’s a patient who…

• Immigrated to the US, and today is his first eye exam

• Is best corrected to 20/80-1 OD and 20/125 OS

• On exam has advanced corneal scarring with corneal opacities and stromal haze

• Pentacam Tomography's look like this

• Pachymetry

• He wants new glasses.

Penetrating Keratoplasty (PK)/(PKP)

• Procedure

• A circular button-shaped full-thickness section of cornea is removed using a trephine or a laser.

• A matching button is removed from the donor cornea.

• The new donor cornea is sewn to the host cornea with sutures.

Post-Operative Course • Often high amount of irregular astigmatism post-operatively

• Incremental suture removal starting at 3-6 months post-op

• Vision and astigmatism fluctuations on every suture removal

• New glasses at 12-18 months post-op. Likely BCVA with specialty contact lenses

• Steroid Medication

Astigmatism becoming more regular.

Drawbacks of PK grafts-graft failure

• 10 years post-op 20 years Post-op 23 years post-op

11 % 51% 83%

Kelly, T., Williams, K., & Coster, D. (2011, June). Corneal Transplantation for Keratoconus. Archives of Ophthalmology, 129(6), 691-697.

Comparison of PK vs. DSEK

0.740.29

4

0.89

0.360.11

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Acuity >20/40 Endothelial Cell loss 1 year Astigmatism

PK

DSEK

Visual Acuity, ECD loss, and Astigmatism

Lee, B., Jacobs, D., Musch, D., Kaufman, S., Reinhart, W., & Shtein, R. (2009, September). Descemet's Stripping Endothelial Keratoplasty: Safety

and Outcomes. American Academy of Ophthalmology, 116(9).

Further Drawbacks of PK grafts-Post-Op visual acuity

• Australian registry study• most recent follow-up

Snellen acuity 20/40 or better in 74%

• AAO registry studyàAchieving 20/40 or better

• PK’s 39% vs. DALK’s 44%

Coster, D. J., Lowe, M. T., Keane, M. C., & Williams, K. A. (2015, May). A Comparison of Lamellar and Penetrating Keratoplasty Outcomes. American Academy of Ophthalmology, 121(5), 979-987.

Kelly, T., Williams, K., & Coster, D. (2011, June). Corneal Transplantation for Keratoconus. Archives of Ophthalmology, 129(6), 691-697.

4/13/17

3

Deep Anterior Lamellar Keratoplasty- DALK

• Here’s a patient who presents to your office..

1. He can’t see

2. His glasses prescription keeps changing

3. Doctors tell him “His eye is bulging forward.”

Deep Anterior Lamellar Keratoplasty-DALK

• Procedure

• Donor graft- Epithelium, Bowman’s, Stroma are dissected out.

• Host- Epithelium, Bowman’s, Stroma are cut out.

• Sutures bring the host and graft together.

VanDijk, K., Baydoun, L., Konder, R., & Melles, G. (2014, August 1). Contact Lenses After Keratoplasty. Contact Lens Spectrum.

DALK vs. PK

• Advantages of DALK1) No open globe

2) Unlikely immune rejection of endothelium

3) Minor loss of endo cells

4) Sutures can be removed earlier

5) Steroids can be stopped earlier

• Major review by AAO for BCVA and preservation of ECD for graft survival• 11 large comparative studies

• 6/11 = BCVA

• other non-determinant

• Graft survivalat 20 years

51% ?PK DALKReinhart, W. J., Musch, D. C., Jacobs, D. S., Lee, B., Kaufman, S. C., &

Shtein, R. M. (2011, January). Deep Anterior Lamellar Keratoplasty as an Alternative to Penetrating Keratoplasty. American Academy of Ophthalmology, 118(1), 209-218.

Amniotic Membrane Grafts

1. Anti-inflammatory

2. Anti-scarring

3. Anti-angiogenesis (new blood vessel growth)

4. Re-epithelialization

http://www.nature.com/eye/journal/v23/n10/fig_tab/eye2008410f2.html

What is amniotic membrane• Inner layer of the placenta

• Avascular connective tissue

• Epithelial cells on a basement membrane which resides over a stromal matrix

• Made of collagen, fibronectin, laminin

• Growth factors

• Anti-inflammatory components

Kenyon, K. R., & Lam, H. (2013, June 1). Amniotic Membrane: Themes and Variations. Ophthalmology Management, 1-6.

Amniotic Membrane Grafts (AMG)

Biotissue- Prokera, Amniograft, & Amnioguard

IOP Ophthalmics-Ambiodisk

http://www.iopinc.com/store/ambiodisk/http://www.biotissue.com/products/prokera.aspx

4/13/17

4

Clinical Usage1. Insertion Prokera vs. AmbioDisk

2. Time-frame to reabsorption = 10-21 days.Resorption will be faster in neovascularized or very inflammed eyes. More inflammatory cytokines will dissolve the graft faster.

3. Prokeraà remove ring in clinic. Ambiodiskà remove BCL

Kenyon, K. R., & Lam, H. (2013, June 1). Amniotic Membrane: Themes and Variations. Ophthalmology Management, 1-6.

AMG Actions

1. Reduces inflammation

2. Inhibits scarring

3. Inhibits angiogenesis

4. Promotes epithelialization

5. Possesses anti-microbial properties

6. Restoration of lost corneal thickness*

Indications/Conditions for use

• Acute corneal trauma

• Chemical or thermal burn

• Non-healing epithelial defects (herpes, diabetes)

• Neurotrophic corneal ulcers

• Filamentary Keratitis

• Severe Dry Eye Syndrome

• Recurring epithelial defects

• High risk keratoplastys

• Superficial keratectomy

• Tube shunt/bleb exposure

• Pterygium removal

Kenyon, K. R., & Lam, H. (2013, June 1). Amniotic Membrane: Themes and Variations. Ophthalmology Management, 1-6.

Here’s a patient who…

• Comes into your office because she can’t see

• 57 y/o female

• Complains of blurry vision worse in the morning.. Gets better

• Vision “Like looking through water”

• Do I have a cataract?

Kaiser, P., Friedman, N., & Pineda II, R. (n.d.). The Massachusetts Eye and Ear Infirmary Illustrated Manual of Ophthalmology: 2nd Edition (Vol. 2). N.p.: Elsevier Health Sciences.

Konan Endothelial Cell Count (ECC) (ECD-Density)

Cornea Fundamentals (2005). In Konan Medical . Retrieved May 23, 2015.Bonnell, A., & Cymbor, M. (2012, August 15). Under the specular microscope. Review of Optometry

Unfortunately- This patient’s ECC

4/13/17

5

Enter DSEK

• Descemet’s Stripping Endothelial Keratoplasty (DSEK/DSAEK)

Removes a. Descemet’sb. Endothelium

Inserta. Posterior Stromab. Descemet’sc. Endothelium

VanDijk, K., Baydoun, L., Konder, R., & Melles, G. (2014, August 1). Contact Lenses After Keratoplasty. Contact Lens Spectrum.

Gas/Air bubble tamponades the graft into place

Post-Operative Course

• Post-Op 1 Day à Patient positioning 1st 24-48 hrs• Vision 20/200-HM, air/gas bubble covering pupil, IOP normal

(ALERT), edematous graft, suture

• Post Op 1 week• Vision 20/30-20/100, air/gas bubble gone or nearly, IOP normal, able

to visualize graft, mild to no edema, suture

• Post-Op 1 month• Vision 20/25-20/50, no bubble, IOP stable, +/--- suture, clear graft

• Post-Op 3 months• Vision stable =1 month, ready for new glasses, IOP stable, clear graft.

ALERT

• If bubble is blocking the PI, the PI is non-patent, or bubble behind Irisè patient will be in pupillary block with elevated IOP• IOP ranges 30-75

• Nausea, headache, vomiting.

• Burping the paracentesis or wound will help.

• If these patients call youàAsk them to sit UP.

A Patient with Fuch’s Dystrophy

• Number 1 concern= Glare

• Vision 20/25 è 20/400

• “I can’t do the things I need to”

• “Scared and nervous”

• Pseudophakic

• His description

The Decision

A. Monitor

B. Muro 128 ointment BID

C. Refer:Endothelial Keratoplasty

D. Look harder for PCO

4/13/17

6

Introducing DMEK

• Descemet’s Membrane Endothelial Keratoplasty

Removes a. Descemet’sb. EndotheliumInserta. Descemet’sb. Endothelium

Gas/Air bubble tamponades the graft into place

Post-Operative Course: Similar to DSEK

• Post-Op 1 Day à Patient positioning 1st 24-48 hrs• 20/200-HM, air/gas bubble covering

pupil, IOP normal (ALERT), edematous graft, suture

• Post Op 1 week• 20/20-20/100, bubble gone or nearly, IOP

normal, able to visualize graft, mild to no edema, suture

• Post-Op 1 month• 20/20-20/50, IOP stable, +/- suture

• Post-Op 3 months• VA stable, ready 4 new glasses, IOP stable

DMEK +/- Cataract Surgery (Triple Procedure)

3.1%

26%30%

0.1

3.5%

26%29%

00.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

early graft failure

median ECD @ 6 months

Air re-injection rate

logMAR bcva

DMEK alone

DMEK+CEX

Chaurasia, S., Price, Jr., F., Gunderson, L., & Price, M. (2014, February). Descemet's Membrane Endothelial Keratoplasty-Clinical Results

of Single Versus Triple Procedures. American Academy of Ophthalmology, 121(2), 454-458.

DMEK vs. DSEK

DMEK vs. DSEK-Acuity

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

pre-op bcva 3-month bcva 6-month bcva

logM

AR

DMEK

DSEK

logMAR 0.6=20/80

logMAR 0.3=20/40

logMAR 0=20/20

Tourtas, T., Laaser, K., Bachmann, B., Cursiefen, C., & Kruse, F. (2012, June). Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty. American Journal of Ophthalmology, 153(6), 1082-1089.

20/100

20/32

20/60

20/25-

20/40-

DMEK vs. DSEK- Pachymetry

0

100

200

300

400

500

600

700

pre-op pach 3-month pach

6-month pach

652

552517

698638 618

DMEK

DSEK

Tourtas, T., Laaser, K., Bachmann, B., Cursiefen, C., & Kruse, F. (2012, June). Descemet Membrane Endothelial Keratoplasty Versus DescemetStripping Automated Endothelial Keratoplasty. American Journal of Ophthalmology, 153(6), 1082-1089.

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7

DMEK vs. DSEK- ECD

0

500

1000

1500

2000

2500

3000

ECD pre-op ECD 3 months PO

ECD 6 months PO

2575

1498 1520

2502

17781532

DMEK

DSEK

Tourtas, T., Laaser, K., Bachmann, B., Cursiefen, C., & Kruse, F. (2012, June). Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty. American Journal of Ophthalmology, 153(6), 1082-1089.

0.7% 1%

9%

12%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

13 month F-U Probability at 2 years

Risk of Transplant Rejection at 1 Year and Probability at 2 Years

DMEK DSEK

Risk of Transplant Rejection

Anshu, A., Price, M., & Price, F. (2012, March). Risk of Corneal Transplant Rejection Significantly Reduced with Descemet's Membrane Endothelial Keratoplasty. Ophthalmology, 119(3), 536-539.

DMEK vs. DSEK- re-bubbling rate

0

5

10

15

20

25

30

35

re-bubbled grafts

DMEK

DSEK

Discussion: “Although a higher re-bubbling rate for DMEK– no effect on visual outcome or endothelial cell survival rate, but was associated with increased post-operative effort”

Tourtas, T., Laaser, K., Bachmann, B., Cursiefen, C., & Kruse, F. (2012, June). Descemet Membrane Endothelial Keratoplasty Versus DescemetStripping Automated Endothelial Keratoplasty. American Journal of Ophthalmology, 153(6), 1082-1089.

27%

44%

0%

39%

0%5%10%15%20%25%30%35%40%45%50%

Re-bubbles needed

Percent decrease in

ECD

Graft Adhesion > Sulfur Hexafluoride (SF6) Gas bubbles for

lower re-bubble rates

Purple = AIRYellow = GAS

Acar, B., Muftuoglu, O., & Acar, S. (2014, March). Comparison of Sulfur Hexafluoride and Air for Donor Attachment in DescemetStripping Endothelial Keratoplasty in Patients with Pseudophakic Bullous Keratopathy. Cornea, 33(3).

Patients Care About Vision.

4/13/17

8

• DMEK

v Maintains corneal anatomy

v Thinner pachymetry

v Equal endothelial cell loss

v With SF6 gas re-bubble rates are lowering, and process is safe for patient

v Less graft rejection

v Better VISION

• DSEK

vAdds thickness to corneal anatomy

vEqual endothelial cell loss

vRe-bubble rates are lowervLess TravelvLess Visits

vWorks well for patients with poor visual potential