Suspension made with amniotic membrane: clinical trial.

Purpose: To investigate if a suspension made with amniotic membrane could have a beneficial effect on ocular surface diseases.

Methods: In the Imola branch of the Eye Bank of Emilia Romagna, the authors prepared a suspension containing homogenized amniotic membrane previously conserved at -80 degrees Celsius. Subsequently, the authors gave this preparation to 21 patients: 8 had undergone lamellar keratoplasty, 4 had undergone penetrating keratoplasty, 2 had undergone photorefractive keratectomy with a delay of epithelialization, 3 had neurotrophic corneal ulcers, 2 had corneal burning, 1 had torpid corneal ulcer, and 1 had Sjogren syndrome. Each patient had been treated with conventional therapy for at least, 4 months without any clinical improvement. In this sample of eyes the authors evaluated the transparency and integrity of epithelium before and after the therapy by means of a fluorescein staining test, examining the area of epithelial defect as well as the phlogistic situation and the symptoms referred by patients. Nine eyes from this group of patients were studied by impression cytology before and after 3 months of use of suspension. The follow-up was 5 months of once-weekly visits.

Results: In all patients, after 15 to 30 days the corneas became negative to fluorescein staining test and the epithelium seemed more complete and regular, there was an evident decrease of phlogistic situation in the conjunctiva, and an improvement of symptoms was referred by patients. The situation was stable during the whole follow-up. No side effects were noted. The impression cytology repeated 3 months after the treatment showed a significant corneal recovery of the cytologic situation with an important decrease of CK19+ cells on the corneal surface.

Conclusions: This new therapy, which is less traumatic than an implant of amniotic membrane, is safe, and can be repeated for a long period, could help patients with corneal superficial defects.