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Randomized Controlled Trial
. 2018 Nov 1;8(1):16168.
doi: 10.1038/s41598-018-34627-w.

Randomised Clinical Trial for Postoperative Complications After Ex-PRESS Implantation Versus Trabeculectomy With 2-Year Follow-Up

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Free PMC article
Randomized Controlled Trial

Randomised Clinical Trial for Postoperative Complications After Ex-PRESS Implantation Versus Trabeculectomy With 2-Year Follow-Up

Shogo Arimura et al. Sci Rep. .
Free PMC article

Abstract

We compared complications between Ex-PRESS implantation and trabeculectomy for 2 years after surgery. Sixty-four open-angle glaucoma eyes were randomly assigned to treatment with trabeculectomy (n = 32) or Ex-PRESS implantation (n = 32). The primary outcomes were postoperative complications, including reduction of the endothelial cell density (ECD) of the cornea, cataract progression and the frequency of other late postoperative complications. The Ex-PRESS group had significantly greater reduction of postoperative corneal ECD than the trabeculectomy group did at 2 years after surgery (P = 0.026). Among the corneal areas measured using specular microscopy, the superior area, where the Ex-PRESS tube was inserted, had significantly more severe corneal ECD reduction than the inferior area after 2 years (-17.6% in superior area and -11.7% in inferior area, P = 0.04). More cataract progression occurred in the trabeculectomy group than in the Ex-PRESS group (P = 0.04). Twelve eyes (37.5%) in the trabeculectomy group and 4 eyes (12.5%) in the Ex-PRESS group underwent cataract surgery (P = 0.019). The total number of other postoperative complications between 3 months and 2 years was significantly higher in the trabeculectomy group than in the Ex-PRESS group (P = 0.02). Although Ex-PRESS implantation might be associated with an increased rate of corneal endothelial cell loss compared with trabeculectomy, it is beneficial for preventing cataract progression after filtering surgery.

Conflict of interest statement

M.I. is responsible for submitting a competing financial interest statement on behalf of all authors of the paper. M.I.’s work has been partially funded by Sumitomo, HOYA, Novartis, Pfizer, Alcon, Senju, Santen, Kowa, MSD, Otsuka, and AMO. The other authors declare no competing interests.

Figures

Figure 1
Figure 1
Comparison of light scattering intensity in lens nucleus after trabeculectomy and Ex-PRESS implantation. Trabeculectomy had a higher intensity of light scattering at 12 and 24 months (P = 0.02 at 12 months; P = 0.04 at 24 months). The data (mean ± standard deviation) were compared using a paired t-test with Bonferroni correction. Cct = the intensity of light scattering per pixel in each layer (Min; 0 steps, Max; 256 steps); Pre-ope = pre-operation; EX = the Ex-PRESS group; Trab = the trabeculectomy group.
Figure 2
Figure 2
Nuclear colour changes based on Lens Opacification Classification System III after trabeculectomy or Ex-PRESS implantation. Trabeculectomy had a higher grade of nuclear colour at 24 months (P = 0.04). The data (mean ± standard deviation) were compared using the paired t-test with Bonferroni correction. Pre-ope = pre-operation; EX = the Ex-PRESS group; Trab = the trabeculectomy group.

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