Evaluation of the role of ProKera in the management of ocular surface and orbital disorders.

OBJECTIVES: To report the efficacy and safety profile of sutureless and adhesiveless amniotic membrane device (ProKera, Bio-Tissue, Inc., Miami, FL) in the management of various ocular surface and orbital disorders. METHODS: Twenty eyes of 20 patients underwent placement of 21 ProKera implants between March 2006 and July 2007 at the University of Texas Southwestern Medical Center. Patient demographics, indications for placement, and duration of ProKera retention were recorded. Outcomes measured included corneal epithelial healing, visual acuity, patient tolerance, and adverse events. RESULTS: ProKera was most commonly used in patients with corneal neovascularization with or without limbal stem-cell deficiency (10 eyes). Other indications included recurrent pterygium or pseudopterygium (three eyes), anophthalmic orbit contraction (two eyes), persistent epithelial defects (two eyes), severe thinning in a corneal ulcer (one eye), benign hereditary intraepithelial dyskeratosis (one eye), and band keratopathy (one eye). The mean duration of ProKera retention was 25.3 days (range, 0-125) visual acuity improved in 12 eyes (60%). Immediate adverse events included residual epithelial defects after removal (five eyes) and spontaneous extrusion of the implant (four eyes). Six patients (30%) reported eye pain or headache and four eyes (20%) had recurrence of the primary pathology. CONCLUSIONS: Sutureless and adhesiveless amniotic membrane transplantation is a safe and effective method to promote healing and reconstruction of the ocular surface and orbit with minimal side effects. Recurrence of the underlying primary pathology remains a concern. The advent of a newer, softer conformer ring may improve patient tolerability and limit discomfort.