CLINICAL

  specialty contact lenses

Biologic Corneal Bandages

Help patients and your practice by employing biologic therapeutics.

STEPHANIE L. WOO, O.D., F.A.A.O., F.S.L.S., LAKE HAVASU, ARIZ.

MR, a 57-year-old white female contact lens wearer, presented with foreign-body sensation, photophobia and pain OS. She said she last wore her lenses three days prior.

Her vision pinholed to 20/30. Upon slit lamp exam, I noted a less than 2mm peripheral ulcer with a positive epithelial defect and mild, diffuse injection. The anterior chamber was deep and quiet.

I prescribed a fourth-generation fluoroquinolone solution q.i.d. Through the next three days of follow-up, the ulcer continued growing, reaching 6mm with irregular borders, despite prescriptions for a new fluoroquinolone q.i.d., an anti-viral solution q.i.d. and a macrolide antibiotic ointment q.h.s. (see figure 1). Culture results were negative for fungus.

Figure 1: MR’s ulcer reached 6mm with irregular borders despite medication.

The ulcer did not respond to conventional therapies, so I employed a biologic corneal bandage. I felt it best to let the amniotic tissue fully dissolve and reassess in a few days. In other cases, drops may be used in conjunction with the amniotic membrane. You are the best person to decide.

Here, I discuss biologic corneal bandages, the ideal candidates, in-office implementation, the associated billing and coding and the aforementioned patient’s current status.

Bandage overview

Biologic corneal bandages are made from an amniotic membrane donated from placentas, which are heavily screened for blood disorders, such as HIV and hepatitis. The tissue is placed on a polycarbonate ring to create an easily insertable ocular device (see figure 2). The device reduces inflammation and promotes regenerative healing by boosting stem cell proliferation on the ocular surface.

Figure 2: Biologic corneal bandages are comprised of a donated amniotic membrane and polycarbonate ring.

Amniotic tissue contains an implicit risk of infectious disease transmissions, however, these devices are checked multiple times, greatly reducing this risk. Other risks: sterile hypopyon (one case) after multiple amniotic membrane placements and post-biological tissue infection, report Current Ophthalmology and Ophthalmology, respectively.

Ideal candidates

Through their anti-inflammatory and healing properties, which aid in the prevention/reduction of corneal scarring and neovascularization, biologic corneal bandages help patients who have non-healing corneal epithelial defects and those who have ocular surface diseases. Patients who have found no relief from artificial tears, gels, punctual plugs, cyclosporine (Restasis, Allergan) drops, etc. may be great candidates for a biologic corneal bandage. They can also benefit patients who have:

▸ Dry eye syndrome (mild, moderate and severe)

▸ Keratitis (microbial and viral)

▸ Recurrent corneal erosion

▸ Filamentary keratitis

▸ Severe infectious keratitis

▸ Acute or chronic superficial keratitis

▸ Post DSEK

▸ Chemical burns

▸ Stevens Johnson syndrome

To learn proper insertion/removal of biologic corneal bandages and acquire related patient education materials, request a company representative come to your practice. Currently, AmbioDisk (IOP Ophthalmics) and Prokera (BioTissue) bandages are available.

Practice implementation

Follow this protocol for biologic corneal bandage candidates in your practice.

1. Provide patient education. Spend five minutes defining the biologic corneal bandage, the insertion and wear process and the treatment’s necessity.

For example: “Mrs. Robinson, I feel our best course of action is a biologic corneal bandage, which will help your eye heal better than other treatments because [insert your clinical findings here]. Your eye will be patched for a week, so if you have any special events coming up, it’s best to schedule this appointment after.” (This script is for a non-urgent patient, such as one with dry eye syndrome. For urgent cases, you would likely insert the bandage that day.)

Also, give the patient a bandage brochure and other related literature to facilitate understanding of how this treatment differs from standard contact lens wear.

2. Get billing staff involved. Have them access the patient’s insurance information, and personally inform the patient either that day or prior to his next appointment of his out-of-pocket cost, if any. This way, the patient is prepared for, rather than surprised by, his coverage.

3. Have a tech set up and take the patient to the exam room. She should place gloves, sterile saline solution, the biologic bandage, forceps, a gauze patch and medical tape in the exam room prior to the patient’s arrival.

4. Insert the biologic corneal lens. Numb the patient’s eye with proparacaine, rinse both sides of the biologic corneal lens with copious amounts of saline solution, and instruct the patient to look down while you use the forceps to insert the device under the upper lid. Next, tell the patient to look straight while you tuck the lower part of the device under the lower lid. (You can utilize fluorescein while the biologic bandage is in place if you want to monitor your patient every few days.) Then, instruct the patient to close the eye so you can place the gauze patch on top, and tape the patch to his face. (Based on the patient’s condition, he may or may not use eye drops for the next few days.)

In most cases, the patch remains in place for a week because doing so ensures the biologic corneal bandage’s full benefits and reduces exposure that may cause amniotic tissue thinning. If the patient uses drops during this time, tape the upper eyelid at the crease. This creates a partial “tarsorrhaphy.” (See figure 3.)

Figure 3: If you decide to use drops while the patient is bandaged, tape the upper eyelid at the crease, which creates a partial tarsorrhaphy.

5. Provide extra patches, and prescribe pain medication. Give the patient a couple extra patches and tape, and tell him where to get more. The patch may get goopy as the amniotic tissue dissolves, and the adhesive from the tape can start to become goopy as well. Also, prescribe a pain drug, should the patient have difficulty sleeping from device-induced foreign-body sensation. (I prescribe a non-narcotic pain reliever 50mg every four to six hours, as needed.)

6. Schedule the patient for a one-week appointment. Remove the patch, instill proparacaine, and remove the device. If the cornea looks about 80% healed, consider this successful, and continue the patient on prophylactic antibiotics for a few days and re-evaluate. If his eye looks only somewhat improved, consider placing another biologic corneal bandage (keep in mind the 10-day global period described below). If the patient’s eye does not look better, I would not repeat the treatment.

Billing and coding

Biologic corneal bandages range from roughly $700 to $950 depending on how many devices you purchase. This translates to $400 to $650 per device to pay for your chair time and patient management. Medicare covers this device at around $1373.78.

Use CPT code 65778 “placement of an amniotic membrane on the ocular surface for wound healing; self-retaining.” (“Self-retaining” means that suture, glue or a bandage lens are not needed to achieve ocular surface retention). This code has a 10-day global period, so you can re-insert another biologic corneal bandage 10 days post the first one.

MR’s current status

MR, the patient mentioned earlier, returned seven days later with a significant reduction in her corneal defect. Vision was 20/20 through pinhole, and I had her continue the fourthgeneration fluoroquinolone t.i.d. and the anti-viral solution q.i.d. for one week. The patient presented two months later sans recurrences and with 20/20 vision. OM

Dr. Woo practices at Havasu Eye Center in Lake Havasu, Ariz. She is a Fellow of the American Academy of Optometry and a Fellow of the Scleral Lens Education Society. Also, she is an advisory board member of GPLI and frequently lectures nationally about specialty contact lenses.