Issue: April 2015
April 01, 2015
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ODs find success with new corneal bandage

Issue: April 2015
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Prokera Slim, a treatment that uses biologically active tissue to heal corneal wounds, has proven to be effective on a range of difficult-to-treat corneal conditions, according to doctors, and provide increased comfort with healing, according to patients.

Bio-Tissue Inc., an ophthalmic biologic therapeutics company, added Prokera Slim and Prokera Plus to its Prokera product line in the fall of 2013.

“The Prokera Slim has amniotic tissue that provides anti-inflammatory and healing properties that help corneal healing,” Carl Spear, OD, FAAO, explained to Primary Care Optometry News.

Bio-Tissue uses a proprietary processing method, CryoTek, when preserving the amniotic membrane tissue in the Prokera products. According to the company, this method ensures that the tissue maintains its biologic active matrix components. On the company’s website, Bio-Tissue states that all donor tissue undergoes screening as well as serological and microbial testing.

“Compared to other products, I use Prokera Slim because of its ease of use and clinical effectiveness,” Thomas P. Kislan, OD, said.

Indications

The original Prokera as well as the Prokera Plus are designed for moderate and severe indications such as neurotropic persistent epithelial defect, corneal wounds, severe infectious keratitis, post-Descemet’s stripping endothelial keratoplasty, bullous keratopathy, severe corneal ulcers, chemical burns and Stevens-Johnson syndrome.

The Prokera Slim in the eye.

The Prokera Slim in the eye.

Post-Prokera removal.

Post-Prokera removal.

Images: Sheha H

The Slim, however, was designed for mild to moderate indications, Kislan said.

“I use it in cases of dry eye, recurrent corneal erosion and severe corneal injuries where I fear there is a risk of future erosion,” he said.

“The growth and healing factors present in Prokera’s amniotic tissue promote the healing of corneal epithelial cells,” Kislan continued. “I use the Slim for International Task Force (ITF) level 3 or 4 dry eye patients, specifically when I have epithelial defects that will not heal, like recurrent erosion. “

David Masihdas, OD, explained that he uses Dry Eye Workshop levels 3 and 4 as his patient treatment guideline, but will also treat chronic level 2 patients.

“The Prokera is not a primary therapy for mild dry eye, but rather for the more severe disease states that have not responded to traditional therapy,” Spear noted.

Using the Prokera Slim

Spear explained that it was a clear choice to use the Prokera Slim in his practice.

“We had used the AmnioGraft amniotic membrane (Bio-Tissue) in our surgical practice, so we had already seen the patient benefit of the amniotic material,” he said. “When the Prokera became available for in-office nonsurgical use, it was an easy decision to adopt the technology.”

Kislan said that the process of inserting the device in a patient’s eye is relatively simple.

“You first apply a topical anesthetic,” Kislan explained “After rinsing the membrane off, have the patient look down, slide the membrane up under the lid and have the patient blink. I prefer to not tape a patient’s lids. I keep patients on all drops and add Lotemax (loteprednol etabonate ophthalmic suspension 0.5%, Bausch + Lomb), to be used before noon, while the Prokera Slim is in.”

He continued: “It’s very easy to use. You just follow the insert and see the patient back in 7 to 10 days. You can do on the other eye, if needed, and can repeat the treatment every 3 to 4 months, if necessary.”

Spear agreed that insertion of the Prokera Slim is straightforward.

Carl Spear, OD, FAAO

Carl Spear

“Optometrists will have no problems with insertion,” Spear added. “I would note that gloves are used since the amniotic membrane is live tissue.”

“Placement of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures,” Bio-Tissue explained on its website.

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Best practice

“It is up to the individual doctor to transition to the next step,” Masihdas said. “There is a little learning curve and a comfort level that has to be attained.

“Use it – it works for the right patients,” he added. “Start with the DEWS levels 3 and 4 first.”

Kislan told PCON that he would recommend it to other doctors as well.

“I actually teach my interns how to use Prokera Slim,” he said.

Although Kislan said he uses the Slim for dry eye patients classified as ITF levels 3 and 4, the device can be useful beyond those categories.

Thomas P. Kislan, OD

Thomas P.
Kislan

“I have started using it more in level 2 patients before they get into situations where healing becomes an issue,” he explained. “I offer it now to patients as an option over moving to plugs and chronic steroid use. It works great with Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan).”

Spear, who has used all of the Prokera products, has found the Slim to be the best fit.

“The thinner profile of the Prokera Slim is more comfortable to patients,” he said. “Although we have used the others as well, the Prokera Slim works well for most cases that are treated in an optometric office.”

Prokera Slim in a petri dish before insertion.

Prokera Slim in a petri dish before insertion.

Prokera Slim in a petri dish after removal. Note how it absorbed the inflammation from the cornea.

Prokera Slim in a petri dish after removal. Note how it absorbed the inflammation from the cornea.

Bio-Tissue warned that Slim is not to be used in eyes with filtering bleb or glaucoma drainage devices.

OD, patient feedback

Spear noted that, occasionally, patients will complain of foreign body sensation when using the Prokera.

“We use a nasal strip in the upper lid fold to minimize lid blink and movement,” he said. “This increases comfort. It is also important to note that topical medications are still used and are instilled in the eye as normal.”

Masihdas and Kislan both reported positive results in their practices, as well as in the eyes of their patients.

“I love the Slim,” Kislan told PCON. “I find it works very well in healing corneas that have areas of persistent epithelial defects. My patients have noticed increased comfort after they see how their eyes have healed.”

Masihdas echoed those sentiments.

“Prokera Slim has made a significant change in our patients’ lives,” he stated. “It gives ODs another option for dry eyes. The vast majority of my patients are extremely happy and satisfied.”

Spear praised the Slim and encouraged other eye care professionals to consider it as a treatment option.

“This is a great device,” he said, “and something that can allow optometrists to provide increased care to patients, so I would absolutely recommend it to other optometrists.” – by Chelsea Frajerman

References:
Prokera. Bio-Tissue website. http://www.biotissue.com/products/prokera.aspx. Accessed February 12, 2015.
For more information:
Thomas P. Kislan, OD, is the founder and medical director of Stroudsburg Eye Specialists, Hazleton Eye Specialists and Dry Eye Clinic of Northeastern PA. He can be reached at foreeyes@ptd.net.
David Masihdas, OD, is in practice at Utah Eye Associates and is the founder of the Diabetic Eye Center. He can be reached at uea@xmission.com.
Carl Spear, OD, FAAO, is the managing partner of Panhandle Vision Group. He can be reached at cspear@icareventures.net.

Disclosures: Kislan has no relevant financial disclosures. Masihdas and Spear are consultants for Bio-Tissue.