Rehabilitative orbital decompression for Graves’ orbitopathy: results of a randomized clinical trial
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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.
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).
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.
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.
KeywordsGraves’ orbitopathy Orbital decompression Diplopia Proptosis Quality of life
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest for this paper.
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 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.
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