Bio-Tissue announced that results from a clinical study demonstrate that its amniotic membrane/umbilical cord grafts are more effective and safer in covering glaucoma drainage devices than traditional pericardium grafts. The results of the study were published in Ophthalmology Glaucoma. This study, a multicenter, randomized, controlled trial was supported by a National Institutes of Health National Eye Institute grant.
The study’s participants comprised adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation. Patients were randomized to receive GDD with either cryopreserved umbilical cord (AM-UC) or pericardium patch grafts to cover GDD tubes. Patients were followed up clinically with anterior-segment OCT to assess patch graft stability and host-tissue integration prospectively.
A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n=72) or Ahmed valve (n=9). Tubes were covered with AM-UC (n=41) or pericardium (n=40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in 1 eye (2%) in the AM-UC group at 3 months and in 2 eyes (5%) in the pericardium group at 2 and 6 months. Sequential anterior-segment OCT showed better host–tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤3 months) occurred in 5 eyes (12%) in the AM-UC group and in 17 eyes (43%) in the pericardium group. Late thinning occurred in 2 eyes (5%) and 11 eyes (28%) in the AM-UC and pericardium groups, respectively. Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.