Advertisement

Efficacy of a Novel Retrobulbar Extension Shunt to Rescue Eyes with Fibrotic Encapsulated Blebs and Uncontrolled Ocular Hypertension

  • William E. Sponsel
  • Sylvia Groth
  • Francesc March de Ribot
  • Hannia Ramos
  • Madeleine PuigEmail author
Glaucoma
  • 14 Downloads

Abstract

Purpose

Retrobulbar glaucoma shunts are large-bore fenestrated silicone stents that redirect aqueous humor into the retrobulbar space. They were designed to rescue failed standard tube shunts with fibrotic encapsulation in patients with intractable ocular hypertension. This article evaluates longer-term outcomes of a larger population undergoing retrobulbar aqueous redirection.

Methods

Outcomes of all retrobulbar shunts were placed among this progressive-entry surgical population over an 8-year interval. Implants were produced by New World Medical (NWM) in Rancho Cucamonga, California, and AJL in Bilbao, Spain. Mean and percentage IOP reduction and medications required were evaluated at annual intervals, along with pre-operative and final visual acuity. Significance of change was assessed by two-tailed paired t-test. Failure was designated as any eye requiring placement of another shunt or diode-cyclophotocoagulation. All data are included in this analysis regardless of outcome.

Results

Thirty-five retrobulbar shunts were implanted (18M, 17F; mean 54.3 years; mean follow-up 32.5 months). Short-term AJL shunt performance was comparable to that of the 26 NWM shunts, for which there was longer-term follow-up. Three shunts (9%) failed: Two eyes required diode at 6 months, one another standard shunt after > 2 years. Preoperative medications averaged 2.6, reduced to 0.4–0.75 medications at each annual assessment (P < 0.0001). IOP was substantially reduced (by 53–57% from mean baseline 29.9–32.5 mmHg to 16.4–18.4 mmHg; P < 0.0008) at every annual follow-up. Visual acuity remained stable (baseline mean VA 0.27, final VA 0.30; P = 0.68).

Conclusion

Retrobulbar extension shunts can convert tube shunt failures, with high success rate, to eyes with IOP control comparable to successful primary filtration surgery.

Keywords

Glaucoma Glaucoma tube shunt Encapsulated bleb Retrobulbar space Intraocular pressure 

Notes

Funding

No funding was received for this research.

Compliance with ethical standards

Conflict of interest

With the single exception listed below, all authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript. William Sponsel is a co-patentee with Mateen Ahmed of New World Medical for the novel concept of shunting aqueous humor into the retrobulbar space. William Sponsel is also a co-patentee with AJL for the bleb-to-back (B2B) and anterior-to-back (A2B) tube shunts.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Quigley HA, Broman AT (2006) The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 90:262–267.  https://doi.org/10.1136/bjo.2005.081224 CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Ramulu P (2009) Glaucoma and disability: which tasks are affected, and at what stage of disease? Curr Opin Ophthalmol 20(2):92–98.  https://doi.org/10.1097/ICU.0b013e32832401a9 CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Prum BE Jr, Rosenberg LF, Gedde SJ et al (2016) Primary open-angle glaucoma preferred practice pattern((R)) guidelines. Ophthalmology 123(1):41–111.  https://doi.org/10.1016/j.ophtha.2015.10.053 CrossRefGoogle Scholar
  4. 4.
    Heijl A, Leske MC, Bengtsson B et al (2002) Reduction of intraocular pressure and glaucoma progression: results from the early manifest glaucoma trial. Arch Ophthalmol 120(10):1268–1279.  https://doi.org/10.1001/archopht.120.10.1268 CrossRefPubMedGoogle Scholar
  5. 5.
    Newman-Casey PA, Robin AL, Blachley T et al (2015) Most common barriers to glaucoma medication adherence: a ross-sectional survey. Ophthalmology 122:1308–1316.  https://doi.org/10.1016/j.ophtha.2015.03.026 CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Friedman DS, Hahn SR, Gelb L, Tan J, Shah SN et al (2008) Doctor-patient communication, health-related beliefs, and adherence in glaucoma: results from the glaucoma adherence and persistency study. Ophthalmology 115:1320–1327.  https://doi.org/10.1016/j.ophtha.2007.11.023 CrossRefPubMedGoogle Scholar
  7. 7.
    Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, Ianchulev T, CyPass Study Group (2016) XEN Glaucoma implant with Mitomycin C 1-year follow-up: result and complications. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology 123(10):2103–2112.  https://doi.org/10.1016/j.ophtha.2016.06.032.20 CrossRefPubMedGoogle Scholar
  8. 8.
    Martorana GM, Schaefer JL, Levine MA, Lukowski ZL, Min J, Meyers CA, Shultz GS, Sherwood MB (2015) Sequential therapy with saratin, bevacizumab and ilomastat to prolong bleb function following glaucoma filtration surgery in a rabbit model. PLoS One 10(9):e0138054.  https://doi.org/10.1371/journal.pone.0138054 CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    HaiBo T, Xin K, ShiHeng L, Lin L (2015) Comparison of Ahmed glaucoma valve implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis. PLoS One 10(2):e0118142.  https://doi.org/10.1371/journal.pone.0118142 CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Gedde SJ, Schiffman JC, Feuer WJ et al (2012) Treatment outcomes in the tube versus trabeculectomy study after five years of follow-up. Am J Ophthalmol 153:789–803.  https://doi.org/10.1016/j.ajo.2011.10.026 CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Christakis PG, Zhang D, Budenz DL, Barton K, Tsai JC, Ahmed IIK, ABC-AVB Study Groups (2017) Five-year pooled data analysis of the Ahmed Baerveldt comparison study and the Ahmed versus Baerveldt study. Am J Ophthalmol 176:118–126.  https://doi.org/10.1016/j.ajo.2017.01.003 CrossRefPubMedGoogle Scholar
  12. 12.
    Barton K, Gedde SJ, Budenz DL, Feuer WJ, Schiffman J, for the Ahmed Baerveldt Comparison Study Group (2011) The Ahmed Baerveldt comparison study: methodology, baseline patient characteristics, and intraoperative complications. Ophthalmology 118(3):435–442.  https://doi.org/10.1016/j.ophtha.2010.07.015 CrossRefPubMedGoogle Scholar
  13. 13.
    Budenz DL, Barton K, Gedde SJ, Feuer JW, Costa VP, Godfrey DG, Buys YM, the Ahmed Baerveldt Comparison Study Group (2015) Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology 122:308–316.  https://doi.org/10.1016/j.ophtha.2014.08.043 CrossRefPubMedGoogle Scholar
  14. 14.
    Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, Ahmed II (2011) The Ahmed versus Baerveldt study: one-year treatment outcomes. Ophthalmology 118:2180–2189.  https://doi.org/10.1016/j.ophtha.2011.05.004 CrossRefPubMedGoogle Scholar
  15. 15.
    Sponsel WE, Groth SL, Ayyala RS (2014) Retrobulbar diversion of aqueous humor: clinical feasibility studies. J Glaucoma 9:628–632.  https://doi.org/10.1097/IJG.0000000000000082 CrossRefGoogle Scholar
  16. 16.
    Schlunck G, Meyer-ter-Vehn T, Klink T, Grehn F (2016) Conjunctival fibrosis following filtering glaucoma surgery. Exp Eye Res 142:76–82.  https://doi.org/10.1016/j.exer.2015.03.021 CrossRefPubMedGoogle Scholar
  17. 17.
    Batlle OR, Sponsel WE, Swann FB, Margo CE, Groth SL, Ayyala RS (2014) Retrobulbar diversion of aqueous humor: laboratory studies. J Glaucoma 9:624–627.  https://doi.org/10.1097/IJG.0000000000000077 CrossRefGoogle Scholar
  18. 18.
    Lee CK, Ma KT, Hong YJ, Kim CY (2017) Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma. PLoS One 12(11):e0187533.  https://doi.org/10.1371/journal.pone.0187533 CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, Morales-Fernandez, Fernandez-Perez C, Garcia-Feijoo J (2016) Glaukos iStent inject® Trabecular Micro-Bypass implantation associated with cataract surgery in patients with coexisting cataract and open-angle glaucoma or ocular hypertension: a long-term study. J Ophthalmol 1056573.  https://doi.org/10.1155/2016/1056573
  20. 20.
    Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, Arrieta E, Peralta AC, Palmberg P, Parrish RK 2nd, Weber BA, Parel JM (2016) Three-year follow-up of a novel aqueous humor microShunt. J Glaucoma 25(2):e58–e65.  https://doi.org/10.1097/IJG.0000000000000368 CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Vision SciencesUniversity of Incarnate WordSan AntonioUSA
  2. 2.Biomedical Engineering University of Texas San AntonioSan AntonioUSA
  3. 3.Vanderbilt University Department of OphthalmologyNashvilleUSA
  4. 4.Barcelona University HospitalBarcelonaSpain
  5. 5.Universidad Autónoma de Guadalajara School of MedicineGuadalajaraMexico
  6. 6.University of Texas Health Science Center at San Antonio Long School of MedicineSan AntonioUSA

Personalised recommendations