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Rehabilitative orbital decompression for Graves’ orbitopathy: results of a randomized clinical trial

  • S. Sellari-Franceschini
  • R. Rocchi
  • M. Marinò
  • A. Bajraktari
  • B. Mazzi
  • G. Fiacchini
  • P. Lepri
  • I. Dallan
  • P. Vitti
  • C. Marcocci
Original Article
  • 60 Downloads

Abstract

Purpose

Orbital decompression (OD) is a consolidated procedure for the treatment of exophthalmos in Graves’ orbitopathy (GO). The efficacy of the various procedures remains unclear due to the variability of the techniques used. To address this issue, we performed a randomized clinical trial to compare the efficacy of two surgical techniques. The primary endpoint was the reduction in proptosis. Secondary aims were the risk of post-operative diplopia (POD) in primary gaze and other surgical complications.

Patients

38 patients (76 orbits) affected with GO were enrolled and randomized into single lateral decompression (LD) (n = 19) or balanced medial plus lateral wall decompression (MLD) (n = 19). Following surgery, patients were seen for a follow-up ophthalmological evaluation at 6 months. Pre-operative diplopia in secondary gaze was present in 13/38 patients (34.2%, 8/19 treated with LD and 5/19 treated with MLD).

Results

The reduction of exophthalmos was greater in patients treated with MLD (5.1 ± 1.5 mm, range 2–8 mm) than in those treated with LD (3.5 ± 1.3 mm, range 1–6.5 mm) (p = 0.01). The overall incidence of POD in primary gaze was 5/38 (13.2%) and all of these patients had pre-operative diplopia in secondary gaze (5/13, 38.5%, vs patients with no pre-operative diplopia p = 0.005). Two of 19 patients (10.5%) treated with LD and 3/19 (15.8%) treated with MLD, developed POD in primary gaze, with no statistical difference between the two techniques.

Conclusion

MLD provides a better result in terms of proptosis reduction compared to LD. The two techniques used here appear to have a similar safety profile in terms of POD. Pre-operative diplopia in the secondary gaze remains a major risk factor for development of POD.

Keywords

Graves’ orbitopathy Orbital decompression Diplopia Proptosis Quality of life 

Notes

Funding

The article was not funded.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest for this paper.

Ethical approval

The study was approved by the local Review Board (Comitato Etico Area Vasta Nord Ovest, Board Affiliation: Comitato Etico Regionale per la Sperimentazione Clinica, Approval Number: 2495).

Informed consent

Informed consent was obtained from an individual participants included in the study. This article does not contain any study with animal performed by any of the authors.

References

  1. 1.
    Piantanida E, Tanda ML, Lai A, Sassi L, Bartalena L (2013) Prevalence and natural history of Graves’ orbitopathy in the XXI century. J Endocrinol Investig 36(6):444–449Google Scholar
  2. 2.
    Anagnostis P, Boboridis K, Adamidou F, Kita M (2017) Natural course of mild Graves’ orbitopathy: is it a chronic remitting or a transient disease? J Endocrinol Investig 40(3):257–261.  https://doi.org/10.1007/s40618-016-0555-0 (Review) CrossRefGoogle Scholar
  3. 3.
    Li HX, Xiang N, Hu WK, Jiao XL (2016) Relation between therapy options for Graves’ disease and the course of Graves’ ophthalmopathy: a systematic review and meta-analysis. J Endocrinol Investig 39(11):1225–1233 (Review) CrossRefGoogle Scholar
  4. 4.
    Bartalena L, Veronesi G, Krassas GE, Wiersinga WM, Marcocci C, Marinò M, Salvi M, Daumerie C, Bournaud C, Stahl M, Sassi L, Azzolini C, Boboridis KG, Mourits MP, Soeters MR, Baldeschi L, Nardi M, Currò N, Boschi A, Bernard M, von Arx G, Perros P (2017) Kahaly GJ; European Group on Graves’ Orbitopathy (EUGOGO). Does early response to intravenous glucocorticoids predict the final outcome in patients with moderate-to-severe and active Graves’ orbitopathy? J Endocrinol Investig 40(5):547–553.  https://doi.org/10.1007/s40618-017-0608-z (Epub 2017 Feb 7) CrossRefGoogle Scholar
  5. 5.
    Bartalena L (2013) Graves’ orbitopathy: imperfect treatments for a rare disease. Eur Thyroid J 2(4):259–269CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Wright ED, Davidson J, Codere F (1999) Desrosiers M. Endoscopic orbital decompression with preservation of an inferomedial bony strut: minimization of postoperative diplopia. J Otolaryngol 28(5):252–256PubMedGoogle Scholar
  7. 7.
    Boboridis KG, Bunce C (2011) Surgical orbital decompression for thyroid eye disease. Cochrane Database Syst Rev 7(12):CD007630Google Scholar
  8. 8.
    Borumandi F, Hammer B, Kamer L, von Arx G (2011) How predictable is exophthalmos reduction in Graves’ orbitopathy? A review of the literature. Br J Ophthalmol 95(12):1625–1630CrossRefPubMedGoogle Scholar
  9. 9.
    Boboridis KG, Uddin J, Mikropoulos GD, Bunce K, Marangouritsas G, Voudouragkaki IC, Konstas AGP (2015) Critical appraisal on orbital decompression for hyroid eye disease: a systematic review and literature search. Adv Ther 32:595–611CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Rocchi R, Lenzi R, Marino M, Latrofa F, Nardi M, Piaggi P, Mazzi B, Altea MA, Pinchera A, Vitti P, Marcocci C, Sellari-Franceschini S (2012) Rehabilitative orbital decompression for Graves’ orbitopathy: risk factors influencing the new onset of diplopia in primary gaze, outcome, and patients’ satisfaction. Thyroid 22(11):1170–1175CrossRefPubMedGoogle Scholar
  11. 11.
    Mourits MP, Prummel MF, Wiersinga WM, Koornneef L (1997) Clinical activity score as a guide in the management of patients with Graves’ ophthalmopathy. Clin Endocrinol (Oxf) 47(1):9–14 (Erratum in: Clin Endocrinol (Oxf) Nov; 47(5):632) CrossRefGoogle Scholar
  12. 12.
    Sellari-Franceschini S, Lenzi R, Santoro A, Muscatello L, Rocchi R, Altea MA, Nardi M, Megna L, Marcocci C (2013) Lateral wall orbital decompression in Graves’ orbitopathy. Int J Oral Maxillofac Surg 39(1):16–20CrossRefGoogle Scholar
  13. 13.
    Olivari N (1991) Transpalpebral decompression of endocrine ophthalmopathy (Graves’ disease) by removal of intraorbital fat: experience with 147 operations over 5 years. Plast Reconstr Surg 87:627–643CrossRefPubMedGoogle Scholar
  14. 14.
    Sellari-Franceschini S, Berrettini S, Santoro A, Nardi M, Mazzeo S, Bartalena L, Mazzi B, Tanda ML, Marcocci C, Pinchera A (2005) Orbital decompression in Graves’ ophthalmopathy by medial and lateral wall removal. Otolaryngol Head Neck Surg 133:185–189CrossRefPubMedGoogle Scholar
  15. 15.
    Wiersinga WM, Perros P, Kahaly GJ et al (2006) Clinical assessment of patients with Graves’ orbitopathy: the European Group on Graves’ Orbitopathy recommendations to generalists, specialists and clinical researchers. Eur J Endocrinol 155:387–389CrossRefPubMedGoogle Scholar
  16. 16.
    Mourits MP, Koornneef L, Wiersinga WM, Prummel MF, Berghout A, van der Gaag R (1990) Orbital decompression for Graves’ ophthalmopathy by inferomedial, by inferomedial plus lateral, and by coronal approach. Ophthalmology 97(5):636–641CrossRefPubMedGoogle Scholar
  17. 17.
    Warren JD, Spector JG, Burde R (1989) Long-term follow-up and recent observations on 305 cases of orbital decompression for dysthyroidorbitopathy. Laryngoscope 99(1):35–40CrossRefPubMedGoogle Scholar
  18. 18.
    Gulati S, Ueland HO, Haugen OH, Danielsen A, Rodahl E (2015) Long-term follow-up of patients with thyroid eye disease treated with endoscopic orbital decompression. Acta Ophthalmol 93(2):178–183CrossRefPubMedGoogle Scholar
  19. 19.
    Metson R, Samaha M (2002) Reduction of diplopia following endoscopic orbital decompression: the orbital sling technique. Laryngoscope 112(10):1753–1757CrossRefPubMedGoogle Scholar
  20. 20.
    Leong SC, Karkos PD, Macewen CJ, White PS (2009) A systematic review of outcomes following surgical decompression for dysthyroidorbitopathy. Laryngoscope 119(6):1106–1115CrossRefPubMedGoogle Scholar
  21. 21.
    Garrity JA, Fatourechi V, Bergstralh EJ, Bartley GB, Beatty CW, DeSanto LW, Gorman CA (1993) Results of transantral orbital decompression in 428 patients with severe Graves’ ophthalmopathy. Am J Ophthalmol 116(5):533–547CrossRefPubMedGoogle Scholar
  22. 22.
    Soares-Welch CV, Fatourechi V, Bartley GB, Beatty CW, Gorman CA, Bahn RS, Bergstralh EJ, Schleck CD, Garrity JA (2003) Optic neuropathy of Graves disease: results of transantral orbital decompression and long-term follow-up in 215 patients. Am J Ophthalmol 136(3):433–441CrossRefPubMedGoogle Scholar
  23. 23.
    DeSanto LW (1980) The total rehabilitation of Graves’ ophthalmopathy. Laryngoscope 90(10 Pt 1):1652–1678PubMedGoogle Scholar
  24. 24.
    Goldberg RA, Shorr N, Cohen MS (1992) The medial orbital strut in the prevention of postdecompression dystopia in dysthyroidophthalmopathy. Ophthal Plast Reconstr Surg 8(1):32–34CrossRefPubMedGoogle Scholar
  25. 25.
    Leone CR Jr, Piest KL, Newman RJ (1989) Medial and lateral wall decompression for thyroid ophthalmopathy. Am J Ophthalmol 108(2):160–166CrossRefPubMedGoogle Scholar
  26. 26.
    Goldberg RA, Perry JD, Hortaleza V, Tong JT (2000) Strabismus after balanced medial plus lateral wall versus lateral wall only orbital decompression for dysthyroid orbitopathy. Ophthal Plast Reconstr Surg 16(4):271–277CrossRefPubMedGoogle Scholar
  27. 27.
    Sellari-Franceschini S, Dallan I, Bajraktari A, Fiacchini G, Nardi M, Rocchi R, Marcocci C, Marino M, Casani AP (2016) Surgical complications in orbital decompression for Graves’ orbitopathy. Acta OtorhinolaryngolItal 36(4):265–274Google Scholar

Copyright information

© Italian Society of Endocrinology (SIE) 2018

Authors and Affiliations

  • S. Sellari-Franceschini
    • 1
  • R. Rocchi
    • 2
  • M. Marinò
    • 2
  • A. Bajraktari
    • 1
  • B. Mazzi
    • 2
  • G. Fiacchini
    • 1
  • P. Lepri
    • 3
  • I. Dallan
    • 1
  • P. Vitti
    • 2
  • C. Marcocci
    • 2
  1. 1.First ENT UnitAzienda Ospedaliero-Universitaria PisanaPisaItaly
  2. 2.Unit of EndocrinologyAzienda Ospedaliero-Universitaria Pisana, University of PisaPisaItaly
  3. 3.Unit of OphthalmologyAzienda Ospedaliero-Universitaria Pisana, University of PisaPisaItaly

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