| Title |
Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial—study protocol
|
|---|---|
| Published in |
BMJ Open, March 2016
|
| DOI | 10.1136/bmjopen-2015-010956 |
| Pubmed ID | |
| Authors |
Ricarda Diem, Fanni Molnar, Flemming Beisse, Nikolai Gross, Katharina Drüschler, Sven P Heinrich, Lutz Joachimsen, Sebastian Rauer, Amelie Pielen, Kurt-Wolfram Sühs, Ralf Andreas Linker, Cord Huchzermeyer, Philipp Albrecht, Andrea Hassenstein, Orhan Aktas, Tanja Guthoff, Felix Tonagel, Christoph Kernstock, Kathrin Hartmann, Tania Kümpfel, Katharina Hein, Christian van Oterendorp, Birgit Grotejohann, Gabriele Ihorst, Julia Maurer, Matthias Müller, Martin Volkmann, Brigitte Wildemann, Michael Platten, Wolfgang Wick, Christoph Heesen, Ulrich Schiefer, Sebastian Wolf, Wolf A Lagrèze |
| Abstract |
Optic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This treatment slightly shortens the time of recovery but does not prevent neurodegeneration and persistent visual impairment. In a phase II trial performed in preparation of this study, we have shown that erythropoietin protects global retinal nerve fibre layer thickness (RNFLT-G) in acute optic neuritis; however, the preparatory trial was not powered to show effects on visual function. Treatment of Optic Neuritis with Erythropoietin (TONE) is a national, randomised, double-blind, placebo-controlled, multicentre trial with two parallel arms. The primary objective is to determine the efficacy of erythropoietin compared to placebo given add-on to methylprednisolone as assessed by measurements of RNFLT-G and low-contrast visual acuity in the affected eye 6 months after randomisation. Inclusion criteria are a first episode of optic neuritis with decreased visual acuity to ≤0.5 (decimal system) and an onset of symptoms within 10 days prior to inclusion. The most important exclusion criteria are history of optic neuritis or multiple sclerosis or any ocular disease (affected or non-affected eye), significant hyperopia, myopia or astigmatism, elevated blood pressure, thrombotic events or malignancy. After randomisation, patients either receive 33 000 international units human recombinant erythropoietin intravenously for 3 consecutive days or placebo (0.9% saline) administered intravenously. With an estimated power of 80%, the calculated sample size is 100 patients. The trial started in September 2014 with a planned recruitment period of 30 months. TONE has been approved by the Central Ethics Commission in Freiburg (194/14) and the German Federal Institute for Drugs and Medical Devices (61-3910-4039831). It complies with the Declaration of Helsinki, local laws and ICH-GCP. NCT01962571. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 33% |
| Unknown | 2 | 67% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Scientists | 1 | 33% |
| Members of the public | 1 | 33% |
| Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
The data shown below were compiled from readership statistics for 94 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 94 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 16 | 17% |
| Student > Ph. D. Student | 12 | 13% |
| Other | 9 | 10% |
| Researcher | 8 | 9% |
| Student > Doctoral Student | 8 | 9% |
| Other | 18 | 19% |
| Unknown | 23 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 34 | 36% |
| Nursing and Health Professions | 11 | 12% |
| Neuroscience | 8 | 9% |
| Biochemistry, Genetics and Molecular Biology | 4 | 4% |
| Psychology | 3 | 3% |
| Other | 6 | 6% |
| Unknown | 28 | 30% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 05 March 2016.
All research outputs
#14,913,921
of 25,371,288 outputs
Outputs from BMJ Open
#15,651
of 25,582 outputs
Outputs of similar age
#151,147
of 312,595 outputs
Outputs of similar age from BMJ Open
#276
of 384 outputs
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