endothelium normal corneal end • extremely thin • innermost layer of cornea • pumps excess...

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  • 6/21/2012

    1

    A Single pass Microkeratome preparation of Ultra-Thin DSAEK

    Grafts in the Eye Bank

    Eric Abdullayev MD,MBA,CEBT

    Director of Clinical Development and Research

    International Sight Restoration Eye Bank

    Tampa , Florida USA Eye Bank Association of America 2012 Annual Meeting

    June 20-23, 2012, Hollywood FL, USA

    Financial Disclosure

    I have no any financial interest in any of the techniques or products

    discussed

    Endothelium

    Extremely thin

    Innermost layer of cornea

    Pumps excess fluid out of the stroma

    Essential in keeping the cornea clear

    Once cells destroyed by disease or trauma, they are lost forever

    Normal Corneal Endothelium

    Primary function of the endothelium is to maintain the health and transparency of the corneal stroma

  • 6/21/2012

    2

    Endothelial Corneal Disease

    Normal corneal endothelium Diseased corneal endothelium-Fuchs

    dystrophy

    Fuchs Distrophy

    Normal endothelial cells

    Density 3200

    GUTTATA cells loss Not suitable for EK or PKP

    Severe Polymegathism

    or large cells

    ( post cataract sx complication)

    Normal endothelial cells

    Density 3200

    Large cells-cells count 1350

    Not suitable for EK or PKP

    Endothelial Corneal Disease Clinical Evaluation

    Clinical Evaluation

    Blurred Vision

    Fluctuating Vision

    Halos around lights

    Photophobia

    Foreign body sensations

    Contact lens intolerance

    Clinical Signs

    Stromal edema

    Increased thickness

    Loss of transparency

    Decreased visual acuity

    Epithelial edema

    Epithelial edema

  • 6/21/2012

    3

    The Traditional Transplant Procedure or Full Thickness Cornea Transplant

    1.White arrow shows opaque,

    damaged cornea

    2.Round shaped portion

    of damaged cornea

    removed

    3. A donor button of clear cornea

    is replaced 4. The donor cornea is sutured

    into place

    The Traditional Transplant Procedure or Full Thickness Cornea Transplant

    DSAEK procedure DSAEK Benefits

    The eye is left much stronger and more resistant to

    injury

    There is minimal change in refractive error because

    the patient's cornea is essentially intact

    Suture-related problems can be eliminated

    Visual recovery is significantly faster and better

  • 6/21/2012

    4

    DSAEK procedure

    Host(recipient) 550 (range:480-650)

    Lenticule(donor) + 150 (50-250)

    Cornea after DSEK = 700 (530-900)

    Too thick of tissue will lead to poor pump function

    INTERNATIONAL SIGHT RESTORATIOB EYE BANK TAMPA FL USA

    FDA- registered

    AHCA- registered

    EBAA- accredited

    -Number donor corneas suitable for DSAEK- 50 - Donor age-between 19 and 79 - Average endothelial cell density before precut - 3155/mm - Central stromal thickness prior precut 493

    Backlight Microscopy Specular Microscopy

  • 6/21/2012

    5

    Backlight Microscopy Back Light Microscopy (Direct) - Normal Cornea

    Back Light Microscopy (Direct) - Epithelial Sloughing

    25x 25x

    40x 25x

    Back Light Microscopy (Distant or Artificial Red Reflex )

    FOLDS

  • 6/21/2012

    6

    Back Light Microscopy (Direct) Endothelial Stress Striae

    40x

    Endothelial stress striae

    Back Light Microscopy (Direct)

    Arcus

    Arcus

    Back Light Microscopy - Artificial Red Reflex Surgical Scars ( cataract surgery)

    Materials and Methods Donor corneas preservation

  • 6/21/2012

    7

    ISO 5 Class Sterile Room with

    Ophthalmic Microscope Ophthalmic Microscope

    Center of donor cornea identified and marked

    Ophthalmic Microscope Tissue mounted on chamber and centered

    Ophthalmic Microscope Epithelium removed during processing

  • 6/21/2012

    8

    Corneal Pachymetry

    (Pachymeter- MMD AP2000)

    Measuring Range : 45 and up

    Corneal Pachymetry (Pachymeter- MMD AP2000)

    Waveform

    measuring the ultra-thin DSAEK

    flap at 56 micron; flap was created by single pass method

    Single Pass Ultra-Thin Graft Preparation

    Increasing stromal resistance by

    raising pressure in the anterior chamber

    Standard pressure up to 90 mmHg Our approach-

    pressure > to 90 mmHg for several seconds

    Graft Preparation Cut Slowly 6 seconds pass

  • 6/21/2012

    9

    Physiology of the cut RESULTS - 50 - donor corneas were prepared using

    pressurized single pass cut:

    *No complication were observed

    - 78.4 - Average central stromal thickness (thinnest graft was 50 and thickest 100 microns)

    - 3132/mm -Average endothelial cell density -

    - 9.76 mm - Cap size

    RESULTS

    63 74

    MICROKERATOME POST-RESECTION

    TISSUE EVALUATION FORM

    ISR EK# OD 2011-0333-OD

    ISR EK# OS n/a

    If cornea(s) to be processed are from source other than ISR, document source eye bank and source tissue #s:

    Eye Bank: n/a Tissue imported by ISR: Y N

    Tissue # OS: n/a Tissue # OD: n/a

    SPECULAR MICROSCOPY

    Cell count prior to resection: 3004 /mm Cell count post- resection: 2934 /mm

    Normal Endothelium Normal Endothelium

    Notes:none Notes: none

    Performed by: E.Abdullayev MD,MBA,CEBT Performed by: E.Abdullayev MD,MBA,CEBT Date: 09/19/2011

    Date: 09/16/2011 POST-RESECTION CELL DENSITY EVALUATION: Pass Fail

    SLIT LAMP/BACKLIGHT MICROSCOPY: POST RESECTION

    EPITHELIUM: Removed during processing Notable defects: none

    ANTERIOR STROMA: Clear

    Centered, Adhered, and aligned with orientation mark (s)

    Notable defects: none

    POSTERIOR STROMA (Graft):

    Clear, no visible decrease in clarity

    Uniform cut, no irregularities or chatter noticed in cut

    Uneven cut; Notes: none

    DESCEMETS MEMBRANE:

    Intact, no folds or defects Folds (rate): few several mild moderate

    central peripheral diffuse

    ENDOTHELIUM:

    Intact, no stress striae or defects Stress striae (rate): few several mild moderate

    central peripheral diffuse

    No significant increase in degree of folds or stress striae Notes: none

    MEASUREMENTS: BED DIAMETER: 10 mm BED THICKNESS (post-resection actual): 72 CAP DIAMETER: 10 mm

    FINAL GRAFT EVALUATION POST-RESECTION: ACCEPTABLE Tissue doesnt meet acceptance criteria for EK ALK

    IF NOT ACCEPTABLE, SPECIFY REASON: n/a

    Evaluated by: MD CEBT: E.Abdullayev MD,MBA,CEBT Evaluated by Medical Director (optional, as needed):

    Date: 09/19/2011 Date:

  • 6/21/2012

    10

    RESULTS

    49 corneas transplanted

    RESULTS Complications

    Graft Failure 1

    Interface Haze -3

    Conclusion

    Our method for single pass microkeratome ultra-thin graft preparation is a safe technique and can be performed in eye-banks with no increased risk of perforation.

    Use of standard Moria equipment eliminates the needs for this procedure-fee increase.

    The prepared ultra-thin graft survives long distance international shipping. Foreign patients can also benefit from this advanced procedure.

    Thank you !!!