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Amniotic membrane platform provides active therapy


Biologic corneal bandage controls inflammation and promotes regenerative healing


A cryopreserved amniotic membrane in a self-retaining device allows early in-office intervention to reduce inflammation and promote regenerative healing in eyes with a variety of ocular surface conditions.


By Cheryl Guttman Krader; Reviewed by Peter R. Andrews, MD

Longmont, CO-The availability of a cryopreserved amniotic membrane in a self-retaining device (ProKera, Bio-Tissue) is a valuable advance for managing eyes with underlying pathology putting them at risk for scarring or poor healing of the ocular surface.

The cryopreserved amniotic membrane is unique because it not only acts as a scaffold for tissue healing, but by virtue of the proprietary cryopreservation process (CryoTek Method, Bio-Tissue), it also retains the native tissue’s extracellular matrix components that have anti-inflammatory activity and promote scarless, regenerative healing. The FDA-cleared device both reduces inflammation and promotes healing, noted Peter R. Andrews, MD, a fellowship-trained cornea specialist in private practice, Eye Care Center of Northern Colorado, Longmont, CO.

Now, with the amniotic membrane available in a 16-mm self-retaining ring, surgeons can place it in an easy in-office procedure (CPT Code 65778) and provide patients with a variety of ocular surface conditions the benefit of more timely intervention that will optimize anatomic and functional outcomes.

“The new amniotic membrane product has been a game-changer in my practice,” Dr. Andrews said. “Previously, I might wait to use amniotic membrane while watching to see how the eye heals passively.

“However, with the convenience of this new platform, I believe that it is in the patient’s best interest to use it early to accelerate healing and control inflammation in order to reduce scarring and optimize visual outcomes,” he added.

Positioning the device

The cryopreserved amniotic membrane in the self-retaining ring is easily placed under topical anesthesia. However, Dr. Andrews noted that the product should be rinsed with sterile saline or eyewash before it is put on the eye, because the packaging solution will cause stinging even in an anesthetized eye.

“This is a minor detail for the procedure, but it is a valuable step for increasing patient acceptance,” he said.

The device centers well, but to help keep it positioned and to minimize discomfort, Dr. Andrews closes the lid with a “tapesorrhaphy,” using Tegaderm tape placed vertically over the lateral lid.

“In certain cases, a true tarsorrhaphy is still a good idea,” he said. “However, the tape alone usually works nicely as an adjunct for holding the device in place.

“In fact, during 5 years of use, I’ve had just a single case where early on, the device was displaced,” Dr. Andrews said. “Its large diameter helps it to stay in place, and after 24 hours, it becomes well-seated.”

Although the patient cannot see well through the device, its presence does not interfere with the surgeon’s ability to evaluate the ocular surface at the slit lamp with fluorescein staining.

Removing the device

When removing the device, Dr. Andrews said he prefers to use an Atkinson forceps that allows him to grab the plastic rim without tearing the membrane. Then, if the eye is not healed, the device can be replaced. Surgeons who do not have access to this particular type of forceps can use their fingers instead.

“The device is easy to remove and replaced like a contact lens, but it should be handled carefully, avoiding sharp toothed forceps,” Dr. Andrews said.

Placement of the cryopreserved amniotic membrane product on the eye does not interfere with the action of topically applied antibiotic or antiviral drops or ointments. Due to the anti-inflammatory activity it provides, use of corticosteroids can be reduced or even eliminated.

“Effective control of inflammation is an important strategy for promoting healing,” he said. “While steroids are often used for this purpose, they are a double-edged sword because they also delay healing and suppress the immune response, which favors ongoing infection.

When using the cryopreserved amniotic membrane, surgeons may treat with a decreased corticosteroid dose or even none at all, and in the long run, achieve better healing with less scarring and a better visual outcome, he noted.

“I have used [the product] successfully in cases of central corneal ulcers in which I thought penetrating keratoplasty would be unavoidable,” Dr. Andrews said. “With the addition of [the device], these eyes healed with reduced scarring and avoided transplantation, which is a much better outcome for the patient.”

Peter R. Andrews, MD

E: pandrews@eccnc.net

Dr. Andrews is a consultant for Bio-Tissue.


Some indications for the therapeutic device

  • Advanced dry eye syndrome

  • Exposure keratopathy

  • Filamentary keratitis

  • Infectious keratitis

  • Neurotrophic persistent corneal epithelial defect

  • PostDSEK for bullous keratopathy

  • PostPRK haze

  • Recurrent corneal erosion

  • Salzmann’s nodular degeneration



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