A Protocol for Use of PROKERA after Corneal Collagen Cross-Linking


With the Federal Drug Administration (FDA) approval of corneal collagen cross-linking (CXL) (Avedro, April 2016) for the treatment of progressive keratoconus, we can expect to see a high volume of these procedures being done by corneal specialists. Although the disease is considered rare, which according to the National Eye Institute (NEI) affects approximately one in every 2,000 Americans, the disease can lead to blindness if not treated. As we know, the surgical technique for performing CXL that is FDA-approved for use in the U.S. at this time is epithelium-off (epi-off, Dresden protocol).

KeratoconusCXL is relatively non-invasive and provides an effective way to intervene early in the disease process and helps to avoid the need for a corneal transplant. Hence, there is much excitement in the ophthalmic community about this new treatment. However, as stated in literature, with the epi-off protocol there is a higher risk of non-healing epithelial defects post-surgery due to the cornea being exposed to the UV radiation for a significant period of time. Avoiding potential complications from non-healing epithelial defects, including infections, scars and haze, is crucial to our CXL patients’ long-term results and visual outcomes.

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After CXL, patients are often fitted with a bandage contact lens (BCL) to alleviate pain and discomfort. They are also prescribed an antibiotic and steroid regimen to try to prevent haze, scar formation and inflammation. However, steroids can also lead to fungal keratitis and delayed healing. When facing a complication after CXL, it is critical to prevent further damage, and to quickly heal the ocular surface so that the patient can return to a healthy lifestyle.

The use of cryopreserved amniotic membrane (PROKERA®) provides the optimal solution for these patients. Bio-Tissue’s proprietary CryoTek® cryopreservation method maintains the structural integrity and key biologics of the amniotic membrane. These include the heavy-chain hyaluronic acid/pentraxin 3 (HC-HA/PTX 3) biologic signaling matrix that is necessary for controlling inflammation and scarring and expediting quality healing.

Since the FDA approval of CXL (AVEDRO) for treating keratoconus, we have been successfully using “A Protocol for Use of PROKERA after Corneal Collagen Cross-linking” in our practice. The objective for treating with PROKERA is to prevent non-healing epithelial defects post-surgery and avoid potential complications including infections, scars, and haze.

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Josh Johnston, ODNeel R. Desai, MD specializes in LASIK, cataract and corneal diseases of the eye. He completed his fellowship training in cornea, cataract and refractive surgery at the Johns Hopkins Hospital, Wilmer Eye Institute. Dr. Desai practices at the Eye Institute of West Florida, and was a Principal Investigator for the FDA clinical trials on the Avedro cross-linking system. He has been elected as a member of the American European College of Ophthalmic Surgeons (AECOS) the Cornea Society, the CEDARS group, and the International Society of Refractive Surgeons.