13 Clinical Trials Summary
13.0 Introduction
13.1 Cornea
13.2 Cataract
13.3 Medical Retina – Age-Related Macular Degeneration (AMD)
13.4 Medical Retina - Diabetes
13.5 Medical Retina – Retinal Vein Occlusion (RVO)
13.6 Vitreoretinal Surgery
13.7 Glaucoma
13.8 Oculoplastics
13.9 Paediatrics
13.10 Neuro-Ophthalmology
13.11 Ocular Oncology
13.10 Neuro-Ophthalmology
ONTT [xcix,c]
18-46 years old
Acute unilateral ON
Visual symptoms ≤ 8/7
RAPD and VF defect
No previous ON
No previous steroid treatment
No systemic disease (other than MS) that could account for this presentation
IVMP – accelerates visual recovery, but no long-term VA benefits
po prednisone – may increase number of new attacks
MS risk – Caucasian, young adult, recurrent ON, female, prior history neurological symptoms, brain MRI lesions, spine MRI lesions, CSF oligoclonal bands
ON risk:
- 50% risk of MS at 15yrs
- Lesions on MRI = risk 75%
- No lesions on MRI = risk 25%
1991. The Clinical Profile of Optic Neuritis: Experience of the Optic Neuritis Treatment Trial. Archives of Ophthalmology 109(12) 1673-1678.
Beck, R.W.M.D., Cleary, P.A.M.S., Anderson, M.M.J.P.A.C. et al. 1992. A Randomized, Controlled Trial of Corticosteroids in the Treatment of Acute Optic Neuritis. The New England Journal of Medicine 326(9) 581-588.
If 1st episode ON & ≥ 2 MRI lesions, give the ONTT regimen, then IM IFNβ-1a weekly to reduce risk of MS from 50% to 33% at 3 years. If low risk give ONTT regimen
10 year results: 40% reduction in CDMS if treated immediately with Avonex i.e. Early treatment of MS reduces long term morbidity
Galetta, S. 2002. The controlled high risk Avonex multiple sclerosis trial (CHAMPS Study). Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society 21 292-295.
Kinkel, R.P., Dontchev, M., Kollman, C. et al. 2012. Association Between Immediate Initiation of Intramuscular Interferon Beta-1a at the Time of a Clinically Isolated Syndrome and Long-term Outcomes: A 10-Year Follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance. Archives of Neurology 69(2) 183-190.
ETOMS [ciii]
Early Treatment of MS
Beta interferon weekly 2 years decrease risk progression to CDMS if given for
- 1 episode of neurological dysfunction +
1MRI lesion
(beta interferon alternate days also decreased conversion to CDMS)
Comi, G., Filippi, M., Barkhof, F. et al. 2001. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357(9268) 1576-1582.
IONTS [civ]
International Optic Nerve Trauma Study
IV steroids or surgical decompression does not improve outcome in traumatic optic neuropathy
- Results limited by small sample size, delay in treatment and a tendency to operate and/or give high dose steroid to patients with very low vision (i.e. NPL) and direct optic nerve injury
Levin, L.A., Beck, R.W., Joseph, M.P. et al. 1999. The treatment of traumatic optic neuropathy: the International Optic Nerve Trauma Study. Ophthalmology 106(7) 1268-1277.
Increased all-cause mortality at 30 days with IV methylprednisolone if significant head injury (GCS < 14)
2005. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury - outcomes at 6 months. The Lancet 365(9475) 1957-1959.
NASCIS [cvi]
National Acute Spinal Cord Injury Study
Spinal cord injury patients with high dose IV methylprednisolone (30mg/kg bolus then infusion) within 8 hours of injury had better motor/sensory outcomes
Young W. NASCIS. National Acute Spinal Cord Injury Study. J Neurotrauma. 1990 Fall;7(3):113-4.
NASCET [cvii]
North American Symptomatic Carotid Endarterectomy Trial
- Stenosis 70 - 99% and symptomatic = surgery (reduced stroke risk at 2 years from 26% to 9% and major/fatal stroke from 13% to 2.5%)
- Stenosis 50 - 69% and symptomatic = maybe surgery
- 100% stenosis = no surgery
- Antiplatelets and statins
Ferguson GG, Eliasziw M, Barr HW et al. The North American Symptomatic Carotid Endarterectomy Trial. Stroke. 1999 Sep;30(9):1751-8.
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13.9 Paediatrics
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Vitreoretinal Surgery Online
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