Article

TREATMENT WITH AMNIOTIC MEMBRANES

THIS VALUABLE HEALING RESOURCE IS AT YOUR DISPOSAL

A 68-year-old white female presents on a Friday morning, 15 minutes before lunch on an already slammed scheduled, complaining of intermittent pain (eight of 10) in her right eye for the past week. Her BCVA is 20/200 OD, 20/20 OS. Her medical history is unremarkable, and she had LASIK OU in 2012 without complications. She says she has not used any lubrication or prescription eye drops and feels like the eye hurts worse when flying. When questioned why she did not come to the office sooner, she states she travels for business five days a week, flying across the country constantly. Examination shows 2+ injection of the conjunctiva and a 5Vx6H mm ulcer, central, including visual axis OD. No cells are present in the anterior chamber, however 2+ flare is present. There’s no papillary or follicular reaction OD. Her left eye appears healthy.

How would you treat this patient’s non-healing corneal ulcer? Here, I provide an overview of my treatment choice, how to use it, how to explain it to patients, how to document and bill for it and the outcome of this choice on the patient mentioned above.

AMNIOTIC MEMBRANE

Amniotic membranes come in varying thicknesses and are made up of a thick basement membrane and an avascular stromal layer derived from a full-term human pregnancy. You can think of an amniotic membrane as an all-natural bandage contact lens that promotes healing and reduces corneal scarring, providing the best visual outcome for patients.

The amniotic membrane is a highly effective treatment for non-healing corneal ulcers (not abrasions), ocular surface cell damage, non-resolving corneal scarring, inflammation or ulceration of the underlying stroma, post-infectious keratitis, non-healing epithelial defects, burns, post-operatively for corneal and pterygium surgical procedures, persistent band keratopathy, bullous keratopathy related to an epithelial defect and chemical burns.

An amniotic membrane should be used when the lesion is not improving after your initial treatment. Never use when there is an active infection. You must demonstrate that first-line treatment has not worked in a timely manner and that without the amniotic membrane, the healing process could result in decreased vision to be reimbursed. (See “How to document and bill” later in this article.)

If a patient presents with a condition you think might benefit from an amniotic membrane, contact your company of choice to supply it.

HOW TO USE IT

There are two types of amniotic membranes: cryopreserved and dehydrated. A well-known example of a cryopreserved amniotic membrane is ProKera (Bio-Tissue) (freezer life two years). The tissue is spread between two clear rings, then placed over the cornea/conjunctiva. Cyropreserved amniotic membranes are cleared by the FDA for protective wound healing and anti-inflammatory effects, according to EyeNet. The AmbioDisk (IOP Ophthalmics) and BioDOptix (BioD) are common dehydrated amniotic membranes (shelf life five years). They are applied to a dry cornea then covered with a bandage contact lens. Dehydrated amniotic membranes are FDA approved for wound coverage, also according to EyeNet. Additional amniotic membranes include OculoMatrix and VisiDisc (Skye Biologics) as well as Aril (Seed Biotech).

Each type of amniotic membrane has its own insertion method.

Cryopreserved amniotic membrane. In a sterile environment, the superior lid is lifted, and the patient looks down, the superior edge of the amniotic membrane is placed on the cornea, then the patient looks up, and the inferior edge of the membrane is placed on the cornea. The patient may feel the ring, but the healing process will start.

Dehydrated amniotic membrane. In a sterile environment, retract the superior and inferior eyelids with lid speculums to prevent blinking contamination of the membrane from any possible bacteria. (If the lid speculum worries your patient, a technician can use two cotton tip applicators to hold the lids.) Anesthetize the eye. Of note: There is a correct side up/down. Before you open the packaging, you’ll want to read the instructions to be certain you put the correct side on the cornea. (If you’re performing the procedure on your own, you may need to open the packaging earlier.) After removing the tissue, lay it flat on the cornea, which should be dry from exposure. Finally, place a bandage contact lens over the membrane, and remove the lid speculums.

With either membrane, you can insert on your own, but having a technician assist will help the process go smoother.

Once either amniotic membrane type is in place, the cornea will appear hazy. (Relax, it’s supposed to look like this.) Until the membrane is dissolved, you will not see clear cornea, and the patient will not see clearly out of that eye. For both membrane types, the tissue should dissolve on its own as the cornea heals. However, remaining tissue attached to the ring of a cryopreserved membrane may need to be removed by the doctor. In the case of dehydrated amniotic membranes, the bandage lens will need to be removed by the doctor, usually three to seven days after application. For these reasons, most follow-ups are scheduled three to four days after insertion. However, follow-up is based on your comfort level. At the follow-up, use sodium fluorescein to determine the extent of healing. Significant healing is expected in one to two days, but complete resolution of the lesion may not be for one week.

68-year-old white female non-healing ulcer
Photo courtesy of Dr. Kaitlyn Rothberg

HOW TO EXPLAIN IT TO PATIENTS

Prior to inserting either amniotic membrane type, explain to the patient that she should expect decreased vision, likely more than he is currently experiencing — especially if you tape the eye shut, such as in cases of photophobia and intolerance of the plastic ring — and improvement in discomfort, even though it may not be immediate. Educating your patient that her vision is going to be blurry is key! The amniotic membrane isn’t a miracle contact lens, and it takes some time to heal.

Next, let the patient know that with the membrane on the eye, she should instill antibiotic drops. (If the eye is taped, no drops should be used.) I recommend using a broad spectrum antibiotic q.i.d., such as a fluoroquinolone. Also, tell her she must not touch the eye or adnexa, unless instilling the antibiotic, because if the amniotic membrane shifts, the desired healing may not occur.

Finally, explain that to achieve a beneficial outcome, there has to be a balance of healing and comfort, meaning she may experience some discomfort, but not to intervene.

HOW TO DOCUMENT AND BILL

Before using an amniotic membrane, you’ll need to document that the standard of care treatment has failed for reimbursement. Therefore, you cannot insert the amniotic membrane on the initial visit. Schedule the follow up for one to two days. If there is not significant improvement, use the amniotic membrane. The coding is CPT code 65778 (+ modifier) with the correct diagnosis code. (Note: No additional codes are necessary when billing this surgical procedure because reimbursement for the cost of the amniotic membrane and the related office visit is included in the reimbursement fee for the procedure.) Cost per amniotic membrane ranges from $550 to $975 per lens, but this is usually discounted when you order a combination pack of multiple membranes. Reimbursement is $1,200 to $1,450 when performing the treatment. (This amount varies by state and the insurance.)

THE PATIENT OUTCOME

That Friday, I inserted a bandage contact lens on her right eye and started a fluoroquinolone q.i.d. At follow-up the following Monday, her right eye had a BCVA of 20/100 after removing the bandage contact lens. She said her pain was mildly improved, but I could see little to no improvement in the ulcer size. This time, I inserted an amniotic membrane, covered it with a bandage contact lens and continued the fluoroquinolone q.i.d. Her VA with the amniotic membrane and bandage contact lens was 20/600. At the one-week follow-up, the amniotic membrane was dissolved when I removed the bandage contact lens, and BCVA was 20/25. The ulcer fully healed with minimal scarring and trace superficial punctate keratitis was all that remained. I then started the patient on a mild steroid t.i.d. to further minimize haze and, hopefully, improve vision to 20/20, which she was, ultimately, able to achieve. Most importantly, my patient was extremely happy with the outcome. OM

Ask for Help!

As with any procedure, I believe experience is the key to expertise. If you are still hesitant and want to dip your toe in the water before jumping in, call a colleague to watch him do the procedure, and observe the follow-up appointments to see the results. Another option? YouTube it. Yes, YouTube has videos on how to apply amniotic membranes, and they are very educational.