Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane

Ocul Surf. 2016 Jan;14(1):56-63. doi: 10.1016/j.jtos.2015.07.003. Epub 2015 Sep 24.


Purpose: To evaluate the clinical efficacy of self-retained cryopreserved amniotic membrane in treating dry eye disease.

Methods: Retrospective review of 10 patients treated with self-retained cryopreserved amniotic membrane (PROKERA® Slim [PKS], Bio-Tissue, Miami, FL) for moderate-to-severe dry eye refractory to conventional maximal medical treatments. Patients' symptoms, use of medications, conjunctival inflammation, corneal staining, and visual acuity were compared before and after treatment.

Results: PKS was placed in 15 eyes of the 10 patients for 4.9 ± 1.5 days. All patients experienced symptomatic relief for a period of 4.2 ± 4.7 months (P<.001). Such improvement was accompanied by reduction of OSDI scores (P<.001), use of topical medications (P<.001), conjunctival hyperemia (P<.001), corneal staining (P<.001), and improvement of the visual acuity (P=.06). Linear regression analysis estimated that the optimal duration of PKS placement was 5 days to achieve an average symptom-free duration of 4 months in patients with dry eye. Surprisingly, PKS placement also generated improvement in the contralateral eyes.

Conclusion: This pilot study suggests that self-retained cryopreserved amniotic membrane via PKS can be used to treat moderate dry eye diseases and warrants further prospective controlled studies.

Keywords: PROKERA®; amniotic membrane; dry eye; keratitis; ocular surface.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Amnion / transplantation*
  • Cryopreservation / methods*
  • Dry Eye Syndromes / physiopathology
  • Dry Eye Syndromes / surgery*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Recovery of Function*
  • Retrospective Studies
  • Visual Acuity / physiology*