Evidence map›Paper›PMID 29450866›Full record

Trial reportJournal of endocrinological investigation2018

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

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of endocrinological investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Orbital wall decompression in the management of Graves' orbitopathy: a systematic review with meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    Pooled it
  4. Trial
  5. Article
  6. Article
  7. [Orbital decompression in Graves' orbitopathy-Experiences and results].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2021
    Article
  8. Review
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

S Sellari-FranceschiniFirst ENT Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
R RocchiUnit of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy. rrocchi63@gmail.com.
M MarinòUnit of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.
A BajraktariFirst ENT Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
B MazziUnit of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.
G FiacchiniFirst ENT Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
P LepriUnit of Ophthalmology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.
I DallanFirst ENT Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
P VittiUnit of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.
C MarcocciUnit of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, Pisa, Italy.
Azienda Ospedaliera Universitaria Pisana · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOrbital 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).

resultsThe 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.

conclusionMLD 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.

Indexed as

AdultCohort StudiesDecompression, SurgicalExophthalmosFemaleFollow-Up StudiesGraves OphthalmopathyHumansMaleMiddle AgedOrbitProspective StudiesYoung AdultDiplopiaGraves’ orbitopathyOrbital decompressionProptosisQuality of life

Identifiers

PMID29450866
OpenAlexW2793155304

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.