A poster presented during the American Academy of Optometry (AAOPT) annual meeting assessed the use of Bio-Tissue Inc.'s self-retained Prokera Slim device for treating patients with moderate to severe dry eye disease (DED).
Refresh me on Prokera.
The Prokera family of products are the only FDA-cleared, therapeutic device that uses cryopreserved amniotic membrane (CAM) to treat anti-inflammation, anti-scarring, and for the promotion of damaged eye surface healing associated with the spectrum of ocular surface disease (OSD).
In essence: it’s designed to provide rapid symptom relief and reduce OSD-associated inflammation to rehabilitate corneal tissue while maintaining comfort.
How does it work?
As a sutureless graft, Prokera is delivered via a self-containing conformer ring—similar to a large contact lens—that ensures its placement is well-centered and in position.
The device can be used to treat a variety of conditions including recurrent corneal erosion (RCE), epithelial basement membrane (EBMD), persistent epithelial defects, and other OSD-related conditions
What’s a typical treatment period?
Typically 3 to 5 days depending on the severity of the condition. An eyecare practitioner (ECP) can elect to extend and/or perform a second treatment once again based on the level of severity.
Within five days of post-treatment, a follow-up visit may be needed to check on progress and potential removal of the device.
Gotcha. And the purpose of this study?
Quite simply: examine the outcomes of DED patients treated with Prokera for 2 days.
Why, exactly?
According to the poster, because no research has yet to determine if placing CAM on DED patients for a shorter period of time would result in clinical benefits similar to that seen when placed on the ocular surface for a 5 to 7-day period.
Now give me the study rundown.
The multi-center, retrospective study enrolled 9 patients (10 eyes; 7 female; 53 to 78 years of age) with moderate to severe DED who were treated with self-retained CAM (Prokera) for 2 days.
Following treatment, additional tape tarsorrhaphy (to protect the corneal surface during the healing process) was used on 30% of the patients.
What kind of ocular discomfort were these patients reporting?
Prior to treatment, patients’ chief complaints included:
- Ocular discomfort (100%)
- Redness (40%)
- Blurred vision (40%)
- Ocular pain (20%)
- Photophobia (10%)
And the findings?
Post-treatment, patients’ Dry Eye Workshop (DEWS) scores were noted as significantly improving:
- 1 week
- 3.1 ± 0.6 at baseline to 1.5 ± 0.5 (p=0.006)
- Months 1 & 2
- 1.2 ± 0.4 at both 1 and 3 months (p=0.004)
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Did corneal staining improve?
Yup—from 3.1 ± 0.6 at baseline to:
- Week 1: 1.1 ± 0.3 (p=0.004)
- Month 1: 1.2 ± 0.6 (p=0.006)
- 3 months: 1.1 ± 0.3 (p=0.004)
And the authors?
There’s quite a few:
- Marguerite McDonald, MD
- Susan Janik, OD
- Frank Bowden, MD
- Amit Chokshi, MD
- Michael Singer, MD
- Sean Tighe, OD, FAAO
- Olivia G. Mead
- Seema Nanda, OD
- Mujtaba Qazi, MD
- Adam Shupe, OD
- Brittany McMurren, OD
Damon Dierker, OD, FAAO, also an author of the study, presented these findings.
So what was the conclusion?
Per the poster findings, the authors concluded that, “a single placement of sutureless CAM for 2 days can significantly improve signs and severity of DED with ocular surface involvement.”
According to Dr. Dierker: “Administering Prokera Slim for just two days and seeing substantial improvements over a three-month period emphasizes the potential for shorter, more efficient treatments in the future.”
These poster findings (#59) were presented at the American Academy of Optometry (AAOPT) annual meeting in New Orleans, Louisiana, October 11-14, 2023.