Abstract
BACKGROUND: To investigate the effectiveness of amniotic membrane transplantation (AMT) on improving the outcomes of trabeculectomy in primary open-angle glaucoma (POAG). METHODS: Fifty-nine eyes affected by primary open-angle glaucoma were enrolled in this prospective randomized study. Thirty-two eyes underwent amnion-shielded trabeculectomy (study group) and 27 eyes underwent trabeculectomy without any antimetabolites (control group). Success was defined as intraocular pressure (IOP) <21 mmHg without any medications at 24 months follow-up. The two groups were compared in terms of IOP, bleb morphology, bleb survival and risk of failure, glaucoma medications, and complications. RESULTS: There was no statistically significant difference in terms of postoperative IOP between the two groups and at 24 months median IOP was 15.5 mmHg for the AMT group and 16 mmHg for the control group. IOP postoperative reduction was 8 mmHg for the AMT group versus 6 mmHg for the non AMT group (P = 0.276). Two patients from the study group developed IOP >21 mmHg in contrast to seven patients from the classic trabeculectomy group. The study group had 61.0% less risk of developing IOP >21 mmHg (P = 0.203). No major complications in the AMT group were observed. AMT blebs were diffuse with mild vascularization. CONCLUSION: In patients with POAG, AMT showed favorable effects on bleb survival, however data failed to provide firm evidence that AMT could be used as a routine procedure in trabeculectomy.