A randomized clinical trial to evaluate the usefulness of amniotic membrane transplantation in bacterial keratitis healing.

PURPOSE: To determine whether early amniotic membrane transplantation improves the outcomes among patients with bacterial keratitis. PATIENTS AND METHODS: In this prospective randomized clinical trial 49 eyes from 49 patients with bacterial keratitis received routine antibiotic therapy followed by double-layer amniotic membrane transplantation during 2-5 days after start up of the medications and the second group of 50 eyes from 50 patients only received routine antibacterial therapy. The main outcomes including visual acuity, corneal healing time, scar size, hypopyon size and duration as well as the depth of corneal opacity and neovascularization were followed for a six months period. In addition, Langerhans cells density and tectonic procedures were documented during the healing period.
RESULTS: Our results indicated statistically significant better best corrected visual acuity (p < 0.001), uncorrected visual acuity (p < 0.001), as well as contact lens corrected visual acuity (p < 0.001) at six months in the case group compared to control group. Corneal healing time, the depth of corneal opacity, hypopyon size and duration were not significantly different in the case group while the scar size (p < 0.001) was significantly smaller. Also significantly less corneal vascularization at six months (p < 0.001) and Langerhans cells density (p < 0.001) at one month were observed in the case group.
CONCLUSION: The early use of amniotic membrane transplantation in treatment of patients with bacterial keratitis was associated with better outcomes compared to antibiotic therapy alone. More comparative studies to investigate the probable side effects as well as the cost benefit of this method are needed.

RCT Entities:   Population Interventions Outcomes