Using amniotic membranes for dry eye patients

Treat dryness-related corneal changes prior to cataract or refractive surgery.

By Brandon Rodriguez, MD

The 52-year-old female patient was a perfect candidate for an amniotic membrane. She complained of decreased visual acuity, problems with glare and dryness. Slit lamp exam revealed evaporative and aqueous tear dysfunction, and I diagnosed the patient with dry eye, blepharitis and meibomian gland dysfunction.

However, after prescribing lid hygiene measures, I found that her visual acuity remained 20/50, and the patient still experienced glare and visual changes related to cataracts.

Amniotic membranes, the inner layer of the fetal membrane, have anti-inflammatory, anti-fibrotic, anti-angiogenic and anti-microbial properties.

While she was a likely candidate for cataract surgery and a toric IOL, she had superficial punctate keratopathy related to her dryness. Therefore, I elected to use a standard IOL after optimizing her ocular surface, which involves lid hygiene, artificial tears, inflammation management in addition to the amniotic membrane. As a result, the patient no longer required a toric IOL, and her visual acuity went to 20/20 after cataract surgery and implanting a standard IOL. If I had implanted a toric IOL, this could have led to lens exchange and an unhappy patient because we would have induced astigmatism when it was not needed.

This demonstrates why we need an amniotic membrane to optimize the ocular surface before proceeding with cataract or refractive surgery.

WHAT IS AN AMNIOTIC MEMBRANE?

Overview

An amniotic membrane, the inner layer of the fetal membrane, has anti-inflammatory, anti-fibrotic, anti-angiogenic and anti-microbial properties. In effect, it creates a fetal environment that promotes corneal healing and helps return the ocular surface to a normal state, which optimizes cataract and refractive surgery outcomes.

Amniotic membranes are indicated for conditions such as recurrent erosion syndrome, infectious keratitis/ulceration, Salzmann’s nodular dystrophy, superficial punctate keratopathy (SPK), epithelial basement membrane dystrophy and neurotropic disease.

Most times when I use amniotic membranes, the patients have been referred by another provider who could not optimize the surface. These patients present because they do not respond to previous dry eye treatment and a more aggressive solution. While we’re now able to use amniotic membranes to treat a variety of conditions, they have yet to become a mainstream treatment for providers with dry eye patients. Early amniotic membranes were only used as a last-ditch effort to save the level of stem cells and the corneal surface for individuals who had cicatrizing conjunctivitities, and unfortunately some individuals still have the mindset that amniotic membranes are only for corneal presentations such as ulcerative keratitis or Stevens-Johnson Syndrome.

Amniotic membranes are not indicated for patients with mild dry eye who don’t experience corneal changes. For these patients, I rely on standard treatments, including artificial tears, topical steroids, such as loteprednol etabonate (Lotemax Gel, Bausch & Lomb), cyclosporine (Restasis, Allergan) and, when indicated, punctal occlusion.

After the insertion

Once the amniotic membrane is inserted, patients can use artificial tears and/or topical cyclosporine, as well as loteprednol etabonate three times per day.

After five days, I see the patient and remove the amniotic membrane if the cornea is no longer stained. If staining persists and the membrane isn’t fully absorbed, I leave it in place for a couple of days.

PROKERA

Progressing from the original

In 2003, the FDA approved ProKera (Bio-Tissue), a sutureless form of amniotic membrane. ProKera features a 16-mm thermoplastic ring that, when placed beneath the upper and lower lids, holds the membrane in place on the affected area of the cornea. ProKera is recommended for patients with moderate to severe indications, such as neuropathic PED, severe infectious keratitis and post-DSEK for bullous keratopathy.

In November 2013, Bio-Tissue introduced its ProKera Slim and ProKera Plus. ProKera Slim, as the name suggests, features a thin profile that contours to the ocular surface to increase comfort. It is indicated for mild-to-moderate ocular surface conditions, such as microbial or HSV keratitis, SPK, recurrent corneal erosions or corneal abrasions.

ProKera Slim’s thinner profile provides improved comfort, which I’ve found helps younger patients’ tolerance because their lids are tighter than older patients. Adults seem to respond well to the classic ProKera due to their lid laxity.

ProKera Plus incorporates multiple layers of amniotic membrane with twice the thickness of the classic ProKera. It is indicated for therapeutic applications that require longer biologic action and durability on the ocular surface, such as chemical burns, Stevens-Johnson Syndrome and severe corneal ulcers.

An effective dry eye treatment

Estimates suggest dry eye prevalence in 5% to 30% in patients over age 50.¹ Dry eye causes include tear film composition changes and age-related changes in how components of the ocular surface system are integrated.²

Before cataract surgery in dry eye patients, using amniotic membranes helps to address these problems and optimize the ocular surface, and my patients are often satisfied with the results.

Dry eye and keratopathy

In my practice, I often see patients with keratopathy secondary to dry eye. I conducted a retrospective study (unpublished) among 40 cataract and dry eye patients averaging 77 years old with longstanding or resistant keratopathy secondary to dryness or associated with acute dry eye disease. The patients received treatment for an average of 294 days before they presented to my clinic, with an average best spectacle-corrected visual acuity of 20/175.

After an average 5.3 days of treatment with amniotic membrane, about 95% of patients achieved resolution of their keratopathy and best spectacle-corrected visual acuity of 20/57. The cryopreserved amniotic membrane rejuvenated the ocular tissue in these patients and optimized the ocular surface, allowing me to treat them using a standard IOL when these patients might have required a toric IOL.

Setting patient expectations

Comfort can be the biggest issue for patients with amniotic membranes — if you’re putting a large 16-mm rigid polymer in the eye that holds amniotic tissue, the patients are going to feel it. Every time I use amniotic membranes, I tell patients they may experience discomfort so I’m setting proper expectations.

Also, because it is a biologically active lens, patients with amniotic membranes often experience blurred vision. When I explain this to patients, I commonly use the comparison of looking through waxed paper.

Helping patients understand these expectations prior to the procedure ensures they will not have any misconceptions.

BENEFITS

Financial reimbursement

Using amniotic membranes offers financial incentive, particularly when looking to grow your practice.

In 2014, CPT amended the code descriptor, which still describes application of a ProKera ring (65778: placement of amniotic membrane on the ocular surface; without sutures).

Payment rates vary by type of provider and site of service. According to Corcoran Consulting Group, 2014 Medicare’s allowed amounts are:

• Physician (in-office): $1,389

• Physician (in-facility): $76

• ASC facility fee: N/A

• HOPD facility fee: $1,193

The large site-of-service difference between physician reimbursement in-office and in-facility is due to the inclusion of ProKera in the facility payment. Keep in mind that these amounts are adjusted in each locality, and other payers set their own fee schedules, which may differ considerably from Medicare rates.

Meeting patient expectations

These days, patients want immediate results, and dry eye is no different. Patient expectations are high with cataract and LASIK surgery. When these surgery candidates have dry eye, we need to make sure the optical surface is healed before taking them to the operating room.

Providing a well-optimized optical surface by getting rid of dryness and lid inflammation only benefits you and your practice by giving you a better chance to provide the patient with the outcome they desire.

Future of amniotic membranes

The list of indications with amniotic membranes has increased dramatically over the last decade, and we need to start thinking about amniotic membranes for patients who experience corneal changes related to dryness. The biggest concern for these patients is inflammatory management, and amniotic membranes are great tools to add to your arsenal and an alternative to having patients take other treatments for months on end with no solution.

Even beyond dry eye, indications for amniotic membranes should continue to grow and become even more valuable to your patients and your practice. OM

REFERENCES

About the Author
	Brandon Rodriguez, MD, specializes in refractive cataract surgery and LASIK at St. Luke’s Cataract & Laser Institute in Tarpon Springs, Fla. Disclosure: Dr. Rodriguez is a a consultant for Allergan, BioTissue, DoctoRx and Nicox.