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Lilach Drori Wagschal, Graham E. Trope, Delan Jinapriya, Yvonne M. Buys; Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy: Interim Results. Invest. Ophthalmol. Vis. Sci. 2011;52(14):615.
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© ARVO (1962-2015); The Authors (2016-present)
To prospectively compare the Ex-PRESS glaucoma device with standard trabeculectomy.
Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. The surgical procedure was standardized and mitomycin C was used in all cases. Primary outcomes were IOP, complete success (IOP between 5-18 mmHg and 20% reduction from baseline without medication) and qualified success (success with the addition of glaucoma therapy). Hypotony was defined as IOP≤4. Secondary outcomes included # of glaucoma medications, visual acuity, complications, pachymetry and endothelial cell counts.
To date 45 subjects have been enrolled, 22 in the trabeculectomy group and 23 in the ExPRESS group. 32 have completed 6 months and 17 have completed 1 year follow-up. At baseline, 6 months and one year the mean IOP was 22.6±8.1 vs 22.6±12.0 (p=0.99), 10.7±4.4 vs 10.1±4.3 (p=0.70) and 14.7± 4.1 vs 10.7±3.6 (p=0.047) in the trabeculectomy vs ExPRESS groups respectively. At 6 months and one year complete success rates were 73% vs 59% (p=0.48) and 29% vs 70% (p=0.15) for the trabeculectomy vs ExPRESS groups respectively. Qualified success rates were 87% vs 69% (p=0.40) at 6 months and 57% vs 80% (p=0.59%) at 1 year for the trabeculectomy vs ExPRESS groups respectively. There were no statistically significant differences in number of glaucoma medications, visual acuity, pachymetry, and endothelial cell count. A similar rate of hypotony was found in both groups.
To date our interim results found no significant difference in complete or qualified success between the groups however at one year the ExPRESS group had a significantly lower mean IOP (p=0.047).
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