Abstract
Purpose :
Historically, amniotic membrane (AM) have been successfully used for wound and reconstructive purpose since the early 20th century, and especially in ophthalmology. A dried AM (D-AM) with a secured manufacturing process (2 viro-inactivations, a lyophilization and a γ-sterilization) was developed by the Tissue Bank of France (TBF) in order to facilitate ophthalmological surgery in terms of handling and storage (at room temperature).
Methods :
Besides the human tissue traceability documents of D-AM, a safety/efficacy register has been proposed to French ophthalmologists for D-AM transplantation procedure. The patient follow-up was performed over a one-month period post-surgery. Data about D-AM indication, reconstruction efficacy (reepithelialisation and thickness), surgery failure or relapse and safety were collected and retrospectively analysed over almost one year.
Results :
724 D-AM transplantations were performed between September 2018 and September 2019. Documented indications highlight a major D-AM use in pterygium surgery (30%) and in persistent corneal ulcers (22%). Other indications were tumour excision (6%), keratitis (5%), bullous keratopathy (2.5%), chemical burn (2%), macular hole (2%), symblepharon (1.5%), graft base (<1%), enucleation ball extrusion (<1%) and non-detailed corneal (9%) or conjunctival (4%) reconstruction; 14% were unknown. 117 cases were included in the register follow-up (September 2018 to July 2019). The medium reepithelialisation time was mainly around 15 days (7 to 29 days) with a total corneal thickness recovery. Only 5% surgery failures and 2% relapses were reported. Regarding safety, D-AM was well tolerated as all reported adverse events were linked to the pathology itself. From a practical perspective, D-AM were used in multilayer for 14% of transplantations, and with an overlay technique only for corneal ulcers in 83% of cases.
Conclusions :
Data collected over this one-year retrospective analysis corroborate with expected D-AM efficacy and safety performances. D-AM was used in several ophthalmological indications, but mostly in ocular surface treatment considering its ability to reduce local inflammation and promote rapid reepithelialisation. D-AM practical uses appear different depending on the type of surgery, with a majority of monolayer procedures. In order to reinforce this database, the register will be continued over a 3 years period.
This is a 2020 ARVO Annual Meeting abstract.