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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. doi: https://doi.org/.
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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.
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%.
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.
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.
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