The use of a cryopreserved amniotic membrane in dry eye disease correlated with corneal nerve regeneration as evidenced by a significant increase in corneal nerve density and corneal sensitivity, according to a study presented at the American Academy of Ophthalmology meeting.
The prospective, controlled study compared self-retained cryopreserved amniotic membrane (Prokera Slim, Bio-Tissue) vs. conventional treatment in patients with moderate to severe dry eye disease.
Twenty subjects were equally randomized to receive Prokera Slim or conventional maximum treatment. The maximal conventional therapy included artificial tears, cyclosporine A, serum tears, antibiotics, steroids and nonsteroidal anti-inflammatory drugs.
Researchers evaluated changes in signs and symptoms, corneal topography, corneal sensitivity and corneal nerve density at baseline, 1 month and 3 months.
Dry eye signs and symptoms were significantly improved in the cryopreserved amniotic membrane (CAM) study group yet remained constant in the control group, according to researchers.
Patients who completed the 1-month and 3-month study with CAM showed significant improvement in their Dry Eye Workshop score, pain score, tear film break-up time, fluorescein staining and Standardized Patient Evaluation of Eye Dryness score, while the control group remained constant, according to the study.
In vivo confocal microscopy in the study group showed a significant increase in corneal nerve density and was accompanied by a significant increase in corneal sensitivity consistent with the change in patients’ dry eye signs and symptoms.
Researchers noted consistent improvement in corneal topography of higher-order aberration in the study group and remained unchanged in the control group.
The placement of self-retained CAM can accelerate the recovery of the corneal surface health that lasts for at least 3 months in patients with moderate and severe DED, researchers concluded.
“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,” researcher Thomas John, MD, said in a press release issued by Bio-Tissue. “Consistent with our findings, cryopreserved amniotic membrane controls inflammation and promotes healing and nerve regeneration.”
John T, et al. Corneal nerve regeneration in dry eye disease. Presented at: American Academy of Ophthalmology; New Orleans; November 11-14, 2017.
Disclosures: The study was supported, in part, by a research grant from TissueTech Inc., Miami. John is a consultant for Bio-Tissue. Sheha and Tighe are employees of TissueTech Inc.