Dry eye is a multifactorial disease comprised of tear film insufficiency and ocular surface involvement. Previous reports have supported the use of amniotic membrane to restore ocular surface health in dry eye disease, but these studies had small sample sizes.^1-3

In this study, amniotic membrane was used to treat dry eye with ocular surface involvement in a larger patient population than has been studied to date.

ABOUT CRYOPRESERVED AMNIOTIC MEMBRANE

Cryopreserved amniotic membrane maintains critical components needed for regenerative healing, primarily heavy chain-hyaluronic acid and pentraxin 3.^4-6 This complex stops the adult inflammatory immune response and provides the eye with the power of fetal healing.^7,8 It suppresses T-cell activation, inhibits giant cell formation, and controls matrix metalloproteinase P production, which promotes regenerative healing.^9,10

Amniotic membrane is full of growth factors that cannot be made in any laboratory, at least not in 2018, and it has collagens type I, type III, type IV, type V, and type VI. It also contains fibronectin and laminin.

STUDY OBJECTIVE AND DESIGN

The purpose of our study was to determine whether a self-retained cryopreserved amniotic membrane (PROKERA® Slim) was effective in treating the ocular surface in severe cases of dry eye disease.¹¹ This retrospective study was conducted at 10 clinical sites to accelerate recovery of ocular surface health in dry eye disease.

The study enrolled 81 patients and treated a total of 97 eyes. Only patients with moderate to severe disease (Dry Eye Workshop [DEWS] levels 3 to 4) who were not responding to maximum conventional therapies were enrolled.

The patients presented with corneal epithelial defects and several types of keratitis (exposure, filamentary, neurotrophic, and superficial punctate). Comorbidities included blepharitis, cataracts, glaucoma, lagophthalmos, and conjunctivitis. Patients received a PROKERA Slim for each study eye and completed an average of 5 days of therapy and at least 3 months of follow-up. The primary outcome measure was the change in the DEWS score after treatment.

STUDY RESULTS

PROKERA Slim was applied for an average of 5.4 days. At the end of that period, 88% of patients demonstrated notable improvement of dry eye symptoms on psychometric testing and an improved ocular surface on slit lamp examination, as judged by the investigators using the DEWS scoring system, and a notable reduction in dry eye severity that lasted at least 3 months, which is when the study ended (Figure 1).

The overall DEWS score was statistically significantly reduced from 3.25 to 1.44 at 1 week, 1.45 at 1 month, and 1.47 at 3 months. Ten percent of the eyes required a second PROKERA Slim. These were primarily in patients who had lagophthalmos or chronic epithelial defects upon entry to the study. Mild discomfort and ring awareness were reported. There were no serious adverse events.

CONCLUSION

The study concluded that placement of self-retained amniotic membrane is a promising therapy to accelerate healing of the ocular surface in patients with moderate to severe dry eye disease. This therapy effectively suppresses inflammation and promotes healing. Further studies will determine longer-term effects and whether or not repetitive use of PROKERA Slim generates a more lasting effect. ●

REFERENCES

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11. McDonald M, et al.; DREAM Study Group. Clin Ophthalmol. 2018.