Dr Hussain Patel, Lilach Drori Wagschal Jinapriya, Graham Trope, Yvonne Buys
To compare the efficacy and safety of the ExPRESSTM minature glaucoma drainage device to tra-beculectomy. Cost differences between the two opera-tions were also compared.
A prospective randomized study. Primary outcomes were IOP and success (IOP between 5–18 mmHg and 20% reduction from baseline with-out medication). Secondary outcomes included number of glaucoma medications,visual acuity, com-plications, pachymetry, endothelial cell count and cost differences.
To date 60 subjects have been enrolled, 30 in each group. 50 have completed the 6 months and 28 completed 1 year follow-up. At baseline, 6 months and 1 year the mean IOP was 24.1 ± 7.4 vs 20.7 ± 10.8 (p = 0.26), 11.2 ± 4.1 vs 10.8 ± 4.7 (p = 0.86) and 14.5 ± 4.4 vs 11.9 ± 3.4 (p = 0.25) in the trabeculec-tomy vs ExPRESSTM groups respectively. At 6 months and 1 year complete success rates were 83% vs 54% (p = 0.20) and 33% and 57% (p = 0.59) in trabeculec-tomy vs ExPRESSTM groups respectively. There were no statistically significant differences in number of glaucoma medications, pachymetry, endothelial cell count, visual acuity or complications. The ExPRESSTM device was associated with a 1-year overall cost of US$933 greater than trabeculectomy.
Our interim results found no statisti-cally significant difference between the ExPRESS and the trabeculectomy groups regarding IOP and com-plications. Ex-PRESSTM is associated with greater cost than trabeculectomy.