Amniotic Membrane ProKera for Ocular Surface Disorders
Materials and Methods
Wills Eye Institutional Review Board approval was obtained for this retrospective chart review of all patients who had ProKera implantation for ocular surface disorders between June 2008 and May 2012 at three ophthalmology practices, including Corneal Associates PC at Wills Eye Institute, Valley Eye Professionals and Ophthalmic Partners of Philadelphia, PA. Patients with at least 1-month follow-up after insertion of device were included. ProKera was inserted as an office-based procedure or in the operating room if associated with other surgical interventions. Written consent was obtained in all patients. When performed in the office, the procedure was performed under topical anesthesia (0.5% proparacaine). The parameters evaluated included patient age and sex, indication for amniotic membrane transplant (AMT), any other procedure combined with the ProKera, time of dissolution of amniotic membrane, the effect of amniotic membrane on ocular surface healing, follow-up time, and complications. The patients were divided into different groups according to the indication for ProKera. Clinical outcome was evaluated as defined by Maharajan et al. The objective of the ProKera was one or more of the following: to promote epithelialization, to prevent corneal perforation, to delay keratoplasty, to limit scarring, and to limit inflammation and vascularization. The outcome was considered successful when the objective(s) was achieved, partially successful when (1) the membrane did not persist long enough but the objective was nevertheless achieved or (2) when there were multiple objectives but only some were achieved. Failure was defined as no objectives were achieved. Additionally, we defined failure as need for further surgical intervention.