Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent

Antonio Maria Fea, Roberta Spinetta, Paola Maria Loredana Cannizzo, Giulia Consolandi, Carlo Lavia, Vittoria Aragno, Francesco Germinetti, Teresa Rolle, Antonio Maria Fea, Roberta Spinetta, Paola Maria Loredana Cannizzo, Giulia Consolandi, Carlo Lavia, Vittoria Aragno, Francesco Germinetti, Teresa Rolle

Abstract

Objective: To evaluate the efficacy and safety of the Xen Gel Stent and provide a macro- and microscopic analyses of bleb morphology.

Methods: A prospective 12-month study on patients with primary open-angle glaucoma. Patients underwent implantation of the XEN Gel Stent (Allergan INC, Dublin, Ireland) either alone or combined with a cataract surgery. Biomicroscopy, in vivo confocal microscopy (IVCM), and anterior segment-optical coherence tomography (AS-OCT) were used to assess bleb morphology. Safety parameters were adverse events, best corrected visual acuity, visual field, and corneal endothelial cell loss. A postoperative IOP ≤ 18 mmHg without or on medications was respectively defined as complete and qualified success while an IOP ≥ 18 mmHg was defined as failure.

Results: Twelve eyes of 11 patients were evaluated. At one year, 5 out of 10 patients available achieved a complete success while five were qualified success. AS-OCT showed that bleb wall reflectivity was significantly higher in the failure group; IVCM revealed that stromal density was significantly lower in the success group. No safety issues were recorded.

Conclusion: Implantation of the XEN Gel Stent appears to be a safe and effective procedure. AS-OCT and IVCM may be helpful in bleb assessment.

Figures

Figure 1
Figure 1
Mean IOP through 12 months postoperative.
Figure 2
Figure 2
Mean number of antiglaucoma medications through 12 months postoperatively.
Figure 3
Figure 3
Pre- and postoperative AS-OCT scans.

References

    1. Razeghinejad M. R., Spaeth G. L. A history of the surgical management of glaucoma. Optometry and Vision Science. 2011;88(1):E39–E47. doi: 10.1097/OPX.0b013e3181fe2226.
    1. Landers J., Martin K., Sarkies N., Bourne R., Watson P. A twenty-year follow-up study of trabeculectomy: risk factors and outcomes. Ophthalmology. 2012;119(4):694–702. doi: 10.1016/j.ophtha.2011.09.043.
    1. Edmunds B., Thompson J. R., Salmon J. F., Wormald R. P. The National Survey of trabeculectomy III. Early and late complications. Eye (London, England) 2002;16(3):297–303. doi: 10.1038/sj/eye/6700148.
    1. Bull H., von Wolff K., Körber N., Tetz M. Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results. Graefe's Archive for Clinical and Experimental Ophthalmology. 2011;249(10):1537–1545. doi: 10.1007/s00417-011-1728-3.
    1. Nichamin L. D. Glaukos iStent trabecular micro-bypass. Middle East African journal of ophthalmology. 2009;16(3):138–140. doi: 10.4103/0974-9233.56227.
    1. Brandão L. M., Grieshaber M. C. Update on minimally invasive glaucoma surgery (MIGS) and new implants. Journal of Ophthalmology. 2013;705915
    1. Stent X. G. , Last accessed August 2, 2016.
    1. Reitsamer H. A., Lenzhofer M., Hohensinn M. H. Ab interno approach to subconjunctival space: first 567 eyes treated with new minimally invasive gel stent for treating glaucoma. Paper presented at: ASCRS. ASCRS/ASOA Annual Symposium and Congress; 2015 Apr 17–21; San Diego, CA. 2015.
    1. Picht G., Grehn F. Classification of filtering blebs in trabeculectomy: biomicroscopy and functionality. Current opinion in ophthalmology. 1998;9(2):2–8. doi: 10.1097/00055735-199804000-00002.
    1. Addicks E. M., Quigley H. A., Green W. R., Robin A. L. Histologic characteristics of filtering blebs in glaucomatous eyes. Archives of Ophthalmology. 1983;101(5):795–798. doi: 10.1001/archopht.1983.01040010795021.
    1. Wells A. P., Crowston J. G., Marks J., et al. A pilot study of a system for grading of drainage blebs after glaucoma surgery. Journal of Glaucoma. 2004;13(6):454–460. doi: 10.1097/00061198-200412000-00005.
    1. Pérez-Torregrosa V. T., Olate-Pérez Á., Cerdà-Ibáñez M., et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Archivos de la Sociedad Española de Oftalmología. 2016;91(9):415–421.
    1. Ciancaglini M., Carpineto P., Agnifili L., et al. Filtering bleb functionality: a clinical, anterior segment optical coherence tomography and in vivo confocal microscopy study. Journal of Glaucoma. 2008;17(4):308–317. doi: 10.1097/IJG.0b013e31815c3a19.
    1. Labbé A., Dupas B., Hamard P., Baudouin C. In vivo confocal microscopy study of blebs after filtering surgery. Ophthalmology. 2005;112(11):p. 1979. doi: 10.1016/j.ophtha.2005.05.021.
    1. Zhu W., Hong J., Zheng T., Le Q., Xu J., Sun X. Age-related changes of human conjunctiva on in vivo confocal microscopy. The British Journal of Ophthalmology. 2010;94(11):1448–1453. doi: 10.1136/bjo.2008.155820.
    1. Leung C. K., Yick D. W., Kwong Y. Y., et al. Analysis of bleb morphology after trabeculectomy with Visante anterior segment optical coherence tomography. The British Journal of Ophthalmology. 2007;91(3):340–344. doi: 10.1136/bjo.2006.100321.
    1. Napoli P. E., Zucca I., Fossarello M. Qualitative and quantitative analysis of filtering blebs with optical coherence tomography. Canadian Journal of Ophthalmology. 2014;49(2):210–216.

Source: PubMed

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