Intervention Review

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Steroids for traumatic optic neuropathy

  1. Patrick Yu-Wai-Man*,
  2. Philip G Griffiths

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 17 JUN 2013

Assessed as up-to-date: 21 MAY 2013

DOI: 10.1002/14651858.CD006032.pub4

How to Cite

Yu-Wai-Man P, Griffiths PG. Steroids for traumatic optic neuropathy. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD006032. DOI: 10.1002/14651858.CD006032.pub4.

Author Information

  1. Royal Victoria Infirmary, Department of Ophthalmology, Newcastle upon Tyne, UK

*Patrick Yu-Wai-Man, Department of Ophthalmology, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP, UK. patrick.yu-wai-man@ncl.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 17 JUN 2013

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Characteristics of included studies [ordered by study ID]
Entezari 2007

MethodsRandomised double-masked placebo controlled
3 months follow-up
Emmam Hossein Medical Center, Iran


Participants31 participants; all men
Age: average age of 29.0±10.2 years (8 to 48)
Treatment group: 30.2±10.6 years
Control group: 28.0±10.9 years

Treatment group: 16 participants
Control group: 15 participants

Inclusion criteria:
1. interval between trauma and admission less than 7 days;
2. eyes with normal fundus; and
3. indirect TON.

Exclusion criteria:
1. penetrating trauma;
2. other accompanying ocular lesions that cause low visual acuity;
3. media haziness;
4. optic nerve avulsion and direct injuries;
5. eyes with TON that needed optic-nerve decompression surgery; and
6. TON with blow-out fracture.


InterventionsTreatment group: 250 mg methylprednisolone intravenously every 6 hours for 3 days, then 1 mg/kg prednisolone orally for 14 days.
Placebo group: 50 ml normal saline intravenously every 6 hours for 3 days, then placebo for 14 days.


OutcomesPrimary outcome: final BCVA (LogMAR)
Secondary outcome: 0.4 LogMAR decrease in final BCVA with respect to initial BCVA


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote p. 1268: " . . the patients were randomly assigned to the control and case groups . . "

Allocation concealment (selection bias)Unclear riskQuote p. 1268: " . . the patients were randomly assigned to the control and case groups according to simple randomization."

Blinding (performance bias and detection bias)
Co-investigators
Low riskQuote p. 1268: "Complete eye examinations were done 1, 2, 3 days, 2 weeks, and 1 and 3 months by another co-investigator, who was blinded to the codes. Another investigator had ordered the treatments."

Blinding (performance bias and detection bias)
Participants
Low riskQuote p. 1268: "The patients also did not know the type of treatment they were receiving."

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote p. 1269: "All the patients were followed-up for 3 months, and there were no missing data."

Selective reporting (reporting bias)Low riskThe published report includes all the expected outcome measures for a trial of this nature.

 
Characteristics of ongoing studies [ordered by study ID]
NCT01783847

Trial name or titleTraumatic Optic Neuropathy Treatment Trial (TONTT)

MethodsMulticentre randomised placebo controlled

Tehran University of Medical Sciences, Iran

Mashhad University of Medical Sciences, Iran

Shaheed Beheshti Medical University, Iran

ParticipantsEstimated enrolment: 100 participants

Inclusion criteria:
1. indirect traumatic optic neuropathy (TON);

2. not more than 3 weeks between trauma and treatment allocation; and
3. normal fundoscopy

Exclusion criteria:

1. other injuries affecting visual function;

2. direct TON;

3. glaucoma; diabetic retinopathy; uncontrolled hypertension; polycythaemia;

4. creatinine more than 3 mg/dl;

5. sensitivity to recombinant human erythropoietin (EPO);

6. hyperkalaemia;

7. women using the contraceptive pill; pregnant and breast feeding women;

8. history of stroke and cardiovascular diseases; and

9. malignancy

InterventionsThe aim of this study is to compare the visual benefit of EPO with steroids or observation alone in indirect TON. Participants will be randomised to one of three treatment groups:

Experimental group: 20,000 units of EPO per day, with intravenous infusions on 3 consecutive days.

Active comparator group: 1 gram of methylprednisolone per day, with intravenous infusions on 3 consecutive days. If visual improvement occurs, the initial treatment phase with intravenous methylprednisolone will be followed by a course of oral steroids (1 mg/kg/day) for 11 days.

Observation group: no treatment will be given.

OutcomesPrimary outcome:

Change in visual acuity from baseline to 3 months after treatment.

Secondary outcomes:

Change in visual acuity, relative afferent pupillary defect, and colour vision from baseline to 1 day, 2 days, 3 days, 1 week, 2 weeks, 1 month, and 3 months after treatment.

Change in visual fields from baseline to 3 months after treatment. This test will only be carried out if the participant's visual acuity is sufficiently good to allow visual fields to be performed reliably.

Starting dateFebruary 2011

Contact informationMohsen B Kashkouli, MD bahmanik@yahoo.com

http://clinicaltrials.gov/show/NCT01783847

NotesThe trial will not be double masked given the different nature of the three treatment groups.