Purpose:
To prospectively compare the Ex-PRESS glaucoma device with standard trabeculectomy.
Methods:
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.
Results:
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.
Conclusions:
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).
Clinical Trial:
REB, 07-0888-A
Keywords: clinical (human) or epidemiologic studies: systems/equipment/techniques • clinical (human) or epidemiologic studies: outcomes/complications