April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy: Interim Results
Author Affiliations & Notes
  • Lilach Drori Wagschal
    Ophthalmology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
  • Graham E. Trope
    Ophthalmology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
  • Delan Jinapriya
    Ophthalmology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
  • Yvonne M. Buys
    Ophthalmology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
  • Footnotes
    Commercial Relationships  Lilach Drori Wagschal, None; Graham E. Trope, None; Delan Jinapriya, None; Yvonne M. Buys, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 615. doi:
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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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Abstract
 
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 
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