OBJECTIVE: 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.
CONCLUSIONS: 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.