June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Prospective Randomized Study Comparing ExPRESS to Trabeculectomy: 1 Year Results
Author Affiliations & Notes
  • Yvonne Buys
    Ophthalmology & Vision Sciences, University of Toronto, Toronto, ON, Canada
  • Lilach Drori Wagschal
    Ophthalmology, Shaare Zedek Medical Center, Jerusalem, Israel
  • Yaping Jin
    Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
  • Delan Jinapriya
    Ophthalmology, Queen's University, Kingston, ON, Canada
  • Graham Trope
    Ophthalmology & Vision Sciences, University of Toronto, Toronto, ON, Canada
  • Footnotes
    Commercial Relationships Yvonne Buys, Alcon Surgical Incorporated (R), Alcon Surgical Incorporated (F), IMED (F); Lilach Drori Wagschal, None; Yaping Jin, None; Delan Jinapriya, Alcon (R); Graham Trope, sensimed (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 2135. doi:
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      Yvonne Buys, Lilach Drori Wagschal, Yaping Jin, Delan Jinapriya, Graham Trope; Prospective Randomized Study Comparing ExPRESS to Trabeculectomy: 1 Year Results. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2135.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: The ExPRESS device was introduced as an alternative to trabeculectomy with anticipated advantages of improved safety and consistency given the standardized lumen size and less tissue manipulation. Of 5 retrospective and 2 prospective studies, one reported more success with ExPRESS and one lower IOP with trabeculectomy. In addition 2 studies reported lower rates of early hypotony and 1 less choroidals following ExPRESS. We designed a prospective RCT to compare the efficacy and safety of ExPRESS to trabeculectomy.

Methods: This study was registered with the NIH (#NCT01263561).Consenting patients with open-angle glaucoma scheduled for filtration surgery were prospectively randomized to trabeculectomy or ExPRESS both with MMC. Exclusion criteria included; previous ocular incisional surgery (exception of clear cornea phaco or one previous trab), uveitis and vitreous in the A/C. The main outcome was IOP. Secondary outcomes included visual acuity (VA), # of glaucoma meds, complications, corneal pachymetry (CCT), endothelial cell counts (ECC), bleb morphology and additional procedures. Standardized data collection sheets were completed at baseline, day 1, weeks 1 & 2 and months 1, 2, 3, 6 and 12 post-op. A sample size calculation determined that 52 eyes were required to detect a 2 mmHg difference with a power of 80%.

Results: 61 of 64 enrolled patients completed 1-yr F/U (31 ExPRESS, 30 Trab). There were no differences in baseline characteristics. The mean baseline IOP decreased from 22.6±10.2 and 22.0±6.8 to 11.0±5.5 and 10.0±4.5 at 1-yr in the ExPRESS and Trab groups respectively (p<0.0001). There was no significant difference in IOP between ExPRESS and Trab groups at any time point. Complete success (IOP 5-18 and 20% reduction from baseline without meds) was obtained in 71% ExPRESS and 57% Trab (p=0.24) and qualified success (± meds) in 87% ExPRESS and 93% Trab (p=0.67). 8 (26%) of the ExPRESS and 10 (33%) of the Trab patients were using glaucoma meds at 1-yr (p=0.58). Of the secondary outcomes the only significant difference was visual recovery which was faster in the ExPRESS group.

Conclusions: At 1-yr we found no statistically significant difference between ExPRESS and Trab groups regarding IOP, success rates, # of glaucoma meds, final VA, CCT, ECC, bleb morphology, complications and additional procedures. However, postoperative VA recovery was faster in the ExPRESS group.

Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 462 clinical (human) or epidemiologic studies: outcomes/complications • 568 intraocular pressure  
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