SUPPLEMENT TO Corneal collagen cross-linking for keratoconus · orneal collagen cross-linking ......

12
FALL 2016 | itech 1 C orneal collagen cross-linking is a treatment for keratoco- nus that was approved in the United States in April 2016. The procedure has long been avail- able in Europe, and Avedro’s approval of Photrexa brings it to many more patients in need. ǯϐ- tion of keratoconus. Understanding keratoconus Keratoconus is a progressive, degen- eration of the cornea which often be- gins in teenagers and slowly pro- gresses at a variable rate for the rest of the patient’s life. It is estimated that the incidence of keratoconus in the United States is about one in 2,000 patients, but that number may be much higher if calculated using modern screening strategies. In some countries, keratoconus is much more common, affecting as many as one pa- tient in 500. Because the cornea is the primary focusing lens of the eye, even mild cases of keratoconus have an effect on the quality of the patient’s vision. The most common early symptom of kera- toconus is blurred vision caused by astigmatism. Keratoconus is almost always bilateral, but it can be more advanced in one eye than the other. ϐǡ correct the vision; however, the amount and axis of the astigmatism in keratoconus changes frequently, and in many patients glasses no lon- ger provide clear vision and contact lenses are often required. Because the astigmatism is asymmetrical, rigid gas permeable contact lenses usually provide the best vision. Most patients can function for years with contact lenses, and in fewer than 10 percent of patients the degeneration becomes severe requir- ing corneal transplantation. Figure 1 shows a side view of a cornea with a cone-shaped protrusion indicating ad- vanced keratoconus. Diagnosing and treating keratoconus Frequent changes in a patient’s pre- scription may be an early sign of kera- Ǥϐ made with corneal topography. The corneal topographic map shows the shape of the cornea, much like a topographic map of the Earth in which red and yellow colors indi- cate a steep curve (mountains), and ϐ curve (oceans and plains). Typically, The recently approved procedure will help many with this progressive disease By James J. Salz, MD Corneal collagen cross-linking for keratoconus Fall 2016 SUPPLEMENT TO Ophthamology Times and Optometry Times Building the Ophthalmic Tech's Community of Practice 1 FIGURE 1 Cornea with advanced keratoconus CROSS-LINKING CONTINUED ON PAGE 4 James J. Salz, MD is clinical professor of ophthalmology at the University of Southern California Roski Eye Insti- tute. [email protected]

Transcript of SUPPLEMENT TO Corneal collagen cross-linking for keratoconus · orneal collagen cross-linking ......

  • FALL 2016 | itech 1

    Corneal collagen cross-linking

    is a treatment for keratoco-

    nus that was approved in the

    United States in April 2016.

    The procedure has long been avail-

    able in Europe, and Avedros approval

    of Photrexa brings it to many more

    patients in need.

    -

    tion of keratoconus.

    Understanding keratoconusKeratoconus is a progressive, degen-

    eration of the cornea which often be-

    gins in teenagers and slowly pro-

    gresses at a variable rate for the rest

    of the patients life. It is estimated

    that the incidence of keratoconus

    in the United States is about one in

    2,000 patients, but that number may

    be much higher if calculated using

    modern screening strategies. In some

    countries, keratoconus is much more

    common, affecting as many as one pa-

    tient in 500.

    Because the cornea is the primary

    focusing lens of the eye, even mild

    cases of keratoconus have an effect on

    the quality of the patients vision. The

    most common early symptom of kera-

    toconus is blurred vision caused by

    astigmatism. Keratoconus is almost

    always bilateral, but it can be more

    advanced in one eye than the other.

    correct the vision; however, the

    amount and axis of the astigmatism

    in keratoconus changes frequently,

    and in many patients glasses no lon-

    ger provide clear vision and contact

    lenses are often required. Because the

    astigmatism is asymmetrical, rigid

    gas permeable contact lenses usually

    provide the best vision.

    Most patients can function for

    years with contact lenses, and in

    fewer than 10 percent of patients the

    degeneration becomes severe requir-

    ing corneal transplantation. Figure 1

    shows a side view of a cornea with a

    cone-shaped protrusion indicating ad-

    vanced keratoconus.

    Diagnosing and treating keratoconusFrequent changes in a patients pre-

    scription may be an early sign of kera-

    made with corneal topography.

    The corneal topographic map

    shows the shape of the cornea, much

    like a topographic map of the Earth

    in which red and yellow colors indi-

    cate a steep curve (mountains), and

    curve (oceans and plains). Typically,

    The recently approved procedure will help many with this progressive diseaseBy James J. Salz, MD

    Corneal collagen cross-linking for keratoconus

    Fall 2016SUPPLEMENT TO Ophthamology Times and Optometry Times

    Building the Ophthalmic Tech'sCommunity of Practice

    1 FIGURE 1 Cornea with advanced keratoconus

    CROSS-LINKING CONTINUED ON PAGE 4

    James J. Salz, MD is clinical professor

    of ophthalmology at the University of

    Southern California Roski Eye Insti-

    tute. [email protected]

    http://www.ubm.com/mailto:[email protected]://optometrytimes.modernmedicine.com/tag/itech

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    Prof. Theo Seiler learned about colla-

    gen cross-linking during a visit to his

    dentist. The dentist was performing

    a procedure to strengthen Dr. Seilers

    gums. The gums were painted with

    were strengthened when they were

    exposed to ultraviolet light for several

    minutes.

    Intrigued by this process, Profes-

    sor Seiler performed experiments

    on rabbit corneas and found that the

    treated corneas were more rigid after

    cross-linking than the control cor-

    neas. He then began a study on pa-

    tients with keratoconus and published

    the preliminary results in 2003.1

    cornea in the horizontal plane, and

    -

    gether by attaching the elements at-

    the inferior part of the cornea in kera-

    toconus becomes steeper, so the map

    shows a red spot in the lower por-

    tion of the cornea (Figure 2 top). As

    the cone progresses, the steep area

    becomes steeper and larger, and the

    astigmatism increases (Figure 2 bot-

    tom right). The area of the cone also

    becomes thinner than the surround-

    ing area.

    The pathology of keratoconus is

    due to an often inherited weakness

    of a portion of the millions of colla-

    !

    of the cornea. Until recently, kerato-

    conus was treated with glasses, con-

    tact lenses, and, in a small percentage

    of patients, with corneal transplant

    (penetrating keratoplasty) surgery

    when the keratoconus progressed to

    the point that contact lenses were no

    longer adequate.

    Now, a procedure called corneal

    cross-linking can halt progression in

    most patients and even cause some

    regression of keratoconus. This pro-

    cedure will dramatically reduce the

    number of patients who will require

    corneal transplants during their life-

    times and provide patients with many

    alternatives for vision improvement.

    Corneal collagen cross-linking therapy""-

    bers leads to a bulging of the cor-

    nea (ectasia). More than 15 years ago,

    Cross-linkingContinued from page 1

    CORNEA

    Investigations are

    underway with

    cross-linking without

    removing the

    epithelium, the epi-on

    procedure

    FIGURE 2

    Top: Corneal maps of inferior steepening typical of early keratoconus in both eyes.

    Bottom: Left, cornea suitable for crosslinking. Right, central cone too steep for crosslinking.

    FIGURE 3

    6FKHPDWLFGLDJUDPRIKRUL]RQWDOFROODJHQEHUVZLWKYHUWLFDOFURVVOLQNV(Image courtesy of Eyemaginations)

    2

    3

  • FALL 2016 | itech 5

    keratoconus was published in 2003

    by Drs. Wollensak, Spoerl, and Seiler2

    in 23 eyes of 22 patients with follow-

    up from three months to four years.

    In all treated eyes, the progression

    of keratoconus was halted. In 16 eyes

    (70 percent), regression with a re-

    duction of the maximal keratometry

    readings by 2.01 D and of the refrac-

    tive error by 1.14 D was found.

    Since that initial report, other

    !

    collagen cross-linking is effective in

    stabilizing most corneas with kerato-

    conus and in many cases reducing the

    magnitude of the cone as evidenced

    by a decrease in the steepest K read-

    ing and a reduction of myopia and/or

    "-

    -

    bers are then stronger, and the num-

    ber of crosslinks increase following

    cross-linking.

    Cross-linking is indicated when

    it can be demonstrated that the cor-

    neal ectasia is progressing over time.

    This can be shown either with in-

    creasing astigmatism and/or an in-

    crease in the keratometry (K) read-

    ings by manual K readings or through

    the topography map. The usual cri-

    teria are an increase in the subjec-

    tive amount of astigmatism of 1.00 D

    or more through refraction, or more

    commonly, objectively with manual K

    readings or on the map, with exams

    one year apart. Corneal thickness

    should be at least 400 m in the thin-

    nest portion of the cornea. In younger

    *"!

    physicians are advocating for treat-

    ment at the time of initial diagnosis

    because these patients are likely to

    progress over their lifetimes.

    The most common method of cor-

    !-

    ally remove the corneal epithelium

    in the epi-off procedure (Figure 4),

    -

    vin drops for about 30 minutes. Once

    -

    side the anterior chamber, visible as

    -

    -

    9

  • CORNEA

    6 itech | FALL 2016

    astigmatism.

    Wollensak3 provided a long-

    term follow-up review of cross-link-

    ing using the Dresden protocol. The

    "

    Dresden clinical study have shown

    that in 60 treated eyes, the progres-

    sion of keratoconus was halted in all

    60 eyes. In 31 of the eyes, there also

    "

    ?

    In another long-term study of 40

    eyes in 32 patients, Haehemi4 con-

    -

    sults, treatment of progressive ker-

    atoconus with corneal cross-linking

    can stop disease progression, with-

    out raising any concern for safety,

    and can eliminate the need for kera-

    toplasty.

    Because cross-linking usually in-

    volves removal of the epithelium and

    ""

    bandage contact lens, complications

    are always possible, just like those

    that might be expected from a pho-

    torefractive keratectomy (PRK) or

    prolonged wearing of soft contact

    lenses.

    Dr. Seilers group performed a

    PubMed search of reported compli-

    cations of corneal crosslinking.5 The

    researchers reported the published

    complication rates of the procedure

    ranged from 1 percent to 10 percent,

    depending on the stage of keratoco-

    nus. Early postoperative complica-

    tions were transient stromal haze,

    !!-

    pensation, delayed epithelial healing,

    and infectious keratitis.

    Stromal opacity (Figure 7) can be

    a delayed postoperative event. In an-

    Q

    linking appears to have a very high

    "!-

    tions.

    Wrapping upCorneal collagen cross-linking is a

    major advance in medicine and for the

    !-

    tunity to stabilize and at times par-

    tially reverse the progressive changes

    usually observed over their lifetime.

    Because keratoconus is a worldwide

    problem affecting thousands of pa-

    tients, the necessity of corneal trans-

    plants and frequent changes in the

    prescription for glasses and contact

    lenses will be dramatically reduced.

    For further reading, Randleman et

    al have published an extensive review

    article with 170 references on corneal

    cross-linking.6

    References

    1. Rush SW,Rush RB. Epithelium-off versus

    transepithelialcornealcollagencrosslinkingfor

    progressivecornealectasia: a randomized and

    controlled trial. Br J Ophthalmol.2016 Jul 7. pii:

    bjophthalmol-2016-308914. doi: 10.1136/bjophthal-

    mol-2016-308914. [Epub ahead of print]

    2. Wollensak G,Spoerl E,Seiler T. Riboflavin/

    ultraviolet-a-inducedcollagencrosslinkingfor the

    treatment ofkeratoconus. Am J Ophthalmol.2003

    May;135(5):620-7.

    3. Wollensak G. Crosslinkingtreatment of progres-

    sivekeratoconus: new hope. Curr Opin Ophthal-

    mol.2006 Aug;17(4):356-60.

    4. Hashemi H,Seyedian MA,Miraftab M,Fotouhi

    A,Asgari S. Corneal collagen cross-linking with

    riboflavin and ultraviolet a irradiation for kerato-

    conus: long-term results. Ophthalmology.2013

    Aug;120(8):1515-20.

    5. Seiler TG, Schmidinger G,Fischinger I,Koller

    T,Seiler T. Complications of corneal cross-linking.

    Ophthalmologe. 2013 Jul;110(7):639-44.

    6. Randleman JB, Khandelwal SS, Hafezi F.

    Corneal cross-linking. Surv Ophthalmol. 2015 Nov-

    Dec;60(6):509-23.

    Cross-linkingContinued from page 5

    7 FIGURE 7 Corneal haze as a complication of cross-linking.

    This procedure will dramatically reduce the

    number of patients who will require corneal

    transplants during their lifetime and provide

    patients with many alternatives for vision

    improvement

  • FALL 2016 | itech 7

    Super optician to the rescue!A Post-It note leads me on a quest to make it right for the patient

    Tami L. Hagemeyer, ABOC, is responsible for optometric and medi-

    cal eye care at Premier Vision Group in Bowling Green, OH.

    [email protected]

    After three glorious vacation

    days, days I spent catch-

    ing up with my family and

    getting some much-needed

    !"

    ciate time off as much as anyone, but

    after a few days away to recharge I

    "!"

    its cheerful photos and framed moti-

    vational messages designed to keep

    me in my imagined happy place. It is

    almost always a pleasure to return to

    my little home-away-from-home" in

    "

    Almost always.

    Post-Its everywhereThis return would have been per-

    fect if it werent for the dreaded Post-

    It notes! These Post-It notes are be-

    coming the bane of my professional

    existence and wreaking havoc in my

    "

    found stuck everywhereon my com-

    puter screen, on my keyboard, and

    this week a Post-It had been placed on

    one of my beloved motivational mes-

    sage frames.

    After a few deep breaths, I began

    perusing through the seven or eight

    Post-Its when one note caught my at-

    tention. It was from the optometrist,

    and said: Mr. Smith stopped in today

    and is noticing blurred vision with his

    new sunglasses. I re-checked his re-

    fraction, and the problem does not

    seem to be with his new prescription.

    I did, however, notice his sun frame

    has quite a curve on it, would you

    please check the base curve?

    He went on to explain the lensom-

    pupillary distance. He wrote, I told

    !!

  • itech | FALL 2016

    tical dilemma.

    I admit I had thoughts of return-

    ing his new sunglasses to our lab for

    a lens evaluation when our patient

    dropped in. It seems he was curious

    about the situation and wondered if

    I had any new thoughts. I spoke with

    complete candor when I told him that

    I was currently working on a solution

    but hadnt found it yet.

    I asked him to put the new sun-

    glasses on and describe exactly what

    he was experiencing. He said his vi-

    sion seemed blurred, and it was im-

    possible for him to read the docu-

    ments on our wall approximately 15

    feet away. He then put on the new

    dress glasses and read the documents

    with complete clarity. I asked to see

    his previous/original sunglasses.

    When he retrieved them from his

    car, to my surprise the lenses had the

    same base curve as his dress glasses,

    which was approximately 6.25 BC OU.

    That seemed a little strange because

    "!-

    cant wrap. When looking directly at

    my patient, I realized the frame had

    a natural wrap from the bridge. The

    new lenses, however, had a base curve

    "?9!

    style. It was becoming clear to me

    what the possible problem might be.

    Making it right for the patientI removed both lenses from the new

    sunglass frame and let them rest

    for about 10 minutes. Then, using my

    lens clock, I checked the base curve

    again. After rest, the lenses were both

    at approximately 7.50 BC. I have a

    TAMI IN THE TRENCHES | One tech's take on the day-to-day job

    shown by the doctor in my ability as

    the answer for the patient. The second

    thing the note meant is that I had some

    serious detective work to do.

    Figuring it out, step by stepI began by reviewing the patients

    comparing it with any changes made

    by the doctor. The changes were mini-

    !

    was an addition of prism in each eye.

    I also noted the chief complaint dur-

    ing his most recent comprehensive

    eye examination of his distance vision

    seeming slightly weaker than during

    his previous examinations.

    It was interesting that my patient

    had also purchased dress glasses that

    were dispensed without any complica-

    tion, which was an indication to me that

    the new prescription was, as the doctor

    thought, probably not the cause.

    The plot thickened as I realized

    the patient had purchased the exact

    frame with the exact style, material,

    and lens tint the year before, so he

    clearly had been comfortable with the

    base curve of the frame and lenses.

    I continued by checking the pupil-

    lary distance, which had not changed

    from the previous year. Every mea-

    !!-

    prit could possibly be the position of

    the frame on his face together with

    the new prisms; the placement of the

    lenses may hold the answer to our op-

    Post-It questContinued from page 7

    !!"

    for occasional lens size corrections. I

    began by re-edging the lensesmin-

    imal edging was necessary because

    I didnt want the lenses too small for

    the frames. I re-mounted them in the

    frame. Much to my relief, the lenses

    seemed better to my patient. His vi-

    sual acuity was improved, and he was

    able to read some of the wall docu-

    ments. Following adjustments to the

    wrap of the frame, our patient began

    to feel more comfortable with his new

    sunglasses. However, in the end I had

    to return the sunglasses to my lab

    because the lenses did not maintain

    their base curve, which did not opti-

    mize my patients new prescription.

    When his sunglasses arrived fol-

    lowing their re-make, I allowed extra

    time during dispensing to talk with

    my patient. We discussed the events

    that had transpired and the many

    steps we had gone through to ensure

    I made certain he understood that

    his visual comfort was our top prior-

    ity. After careful alignment, his visual

    acuity seemed perfect.

    "

    that although he had to make several

    "

    second, and the extra attention as-

    sured him that he is a valued patient.

    Although my patient had to wait an

    additional three days to receive his

    new sunglasses, I had been able to re-

    making a return visit probable.

    I dont think of myself as a super

    !

    !-

    mas. I also take great pleasure in de-

    veloping an understanding of trust

    with the doctortogether we recog-

    nize each individual patient and his

    importance to our practices contin-

    ued growth.

    Although my patient had to wait an additional three

    days to receive his new sunglasses, I had been able

    WRUHVWRUHKLVFRQGHQFHLQRXUSUDFWLFHPDNLQJD

    return visit for his eyewear probable

  • FALL 2016 | itech 9

    ETHICS

    The ethics of care for technicians8QGHUVWDQGKRZDXWRQRP\MXVWLFHEHQHFHQFHDQGnon-malfeasance come into play

    I have often wondered why there

    are a limited number of ethics

    classes available for technical

    staff to take

    While the doctors have the Hippo-

    cratic oath that binds them to their

    areas of practice, where is the oath

    that the technical staff takes to en-

    sure we are all working under the

    same premise?

    We know that our role is to ensure

    that the patient is protected, physi-

    cally cared for, and that all caregiv-

    ers are responsible to ensure that

    we always do the right thing when

    it comes to their care. But where do

    these tenets come from and what do

    they actually mean to us?

    'HQLQJHWKLFVAccording to the Oxford Dictionary,

    ethics are the moral principles that

    govern a person's or groups behav-

    ior. Ethics deal with right and wrong

    types of behaviorwhat we ought

    to do. Ethics are a set of moral prin-

    ciples and the code of behavior that

    governs an individuals actions with

    other individuals in a society. We

    need to be aware that ethics can, and

    do, differ among cultures.

    Laws are not ethics. Laws are so-

    -

    ments for violations; ethics do not

    have established punishments.

    Every day, we are put in the posi-

    tion to determine what is right and

    wrong about a given situation or our

    behavior.

    Medical ethics are simply ethics as

    they are applied to medicine.

    Tom L. Beauchamp and James F.

    Childress, authors of Principles of Bio-

    medical Ethics, determined that med-

    ical ethics work with the principles

    "!{

    non-malfeasance.

    AutonomyAutonomy addresses respect that a

    patient has the ability to make deci-

    sions for his own care. This respect

    works with the belief that the patient

    has the capacity, and the right, to

    think, decide, and act on his own be-

    half regarding his care.

    The patient needs to be able to

    make a rational, informed, and un-

    coerced decision. In order to do this,

    he must be given the information to

    make that decision and have the abil-

    ity to ask questions of the doctor to

    make sure he has all the information

    he needs. Note that the patient must

    be able to ask questions of the doctor,

    not the technician or nurse.

    The concept of autonomy leads to

    informed consent. This means that a

    patient cannot have any medical in-

    tervention for diagnostic, investiga-

    tional, or palliative purposes without

    granting permission. The patient must

    "

    the intervention. Informed consent

    encompasses more than asking a pa-

    tient to sign a written consent form.

    "

    communication between the patient

    and the responsible physician who is

    providing the care that results in the

    patient's authorization and/or agree-

    !!-

    tervention.

    For example, if your patient is

    scheduling surgery, the doctor should

    discuss the procedure, the hoped-

    for outcome, and any potential risks.

    Informed consent is a conversation

    which takes place before the form is

    signed. Be sure the form is signed in

    "!-

    tient. You cant be sure that your pa-

    By Dianna E. Graves, COMT, BS, Ed

    Dianna Graves is clini-

    cal services manager at

    St. Paul Eye Clinic PA, in

    Woodbury, MN. TECH ETHICS CONTINUED ON PAGE 10

  • 10 itech | FALL 2016

    ETHICS| Do the right thing with patient care

    sion must be made on the facts on pa-

    tients medical conditions, not on race,

    ability to pay, creed, religion, or per-

    sonality. The patient with a lacerated

    eyelid is going to be seen before all

    the other patients, regardless of their

    appointment times.

    %HQHFHQFH!

    ""

    help prevent harm, to remove harm,

    or to improve the situation of others.

    It requires that any intervention that

    is given will be given with the intent

    of doing good for the patient.

    Non-malfeasanceNon-malfeasance requires that any

    procedure done to a patient does not

    harm the patient involved or others in

    society. From this the concept of do

    no harm arises.

    Non-malfeasance protects the pa-

    tient from physicians who provide in-

    effective treatments to a patient even

    if the patient asks for that treatment.

    More ethical considerationsTwo other areas also address ethics

    attitude.

    One of these areas

  • How do we help ensure your patients are paying the lowest out-of-pocket cost for EYLEA? Simple: EYLEA4U. EYLEA4U helps patients access EYLEA with the enhanced EYLEA Co-Pay Card, referrals to co-pay assistance foundations, and our Patient Assistance Program.

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