At the recent American Academy of Ophthalmology Meeting in New Orleans, I presented on results of “Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease” recently published in The Journal of Ophthalmology, 2017 (John, et al.). This study is the first study to show that cryopreserved amniotic membrane is correlated with corneal nerve regeneration in patients with dry eye disease (DED).

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An illustrative example of fluorescein staining before (left) and after (right) PROKERA Slim (PKS) treatment. (Image courtesy of Thomas John, MD)

In this prospective, randomized controlled clinical trial, 20 patients with DED were randomly treated with cryopreserved amniotic membrane (PROKERA), or conventional maximum treatment (control). PROKERA was found to be a promising therapy for corneal nerve regeneration and to accelerate the recovery of ocular surface health in patients with moderate and severe DED.

In the clinical trial, patients who completed the one-month and three-month study with cryopreserved amniotic membrane (PROKERA) showed significant improvement in their DEWS score, pain score, TFBUT, fluorescein staining, and SPEED score. Further, these patients exhibited a significant increase in central corneal nerve density both at the one-month and three-month periods, and significant improved corneal sensation from a baseline of 3.25 ± 0.6 cm to 5.2 ± 0.5 cm at one-month and 5.6 ± 0.4 cm at three-months. There was also improved corneal surface topography in terms of wavefront aberrations as well as the cylinder that is induced in dry eye patients. These results were confirmed by a masked reader at Tufts Medical Center in Boston.

These findings are quite significant as this is the first study to demonstrate that cryopreserved amniotic membrane is correlated with corneal nerve regeneration, as evidenced by an increase in corneal nerve density and improved corneal sensitivity. Prior to this study, no therapeutic modality was shown to regenerate corneal nerves, which play a key role in tear film stability and ocular surface health. Consistent with our findings, cryopreserved amniotic membrane controls inflammation and promotes healing and nerve regeneration.


Thomas-John-200x200.pngThomas John, MD is a world renowned ophthalmic surgeon and has published and lectured extensively. Dr. John is in private practice in the suburbs of Chicago.