Multicenter-study of the European Assessment Group for Lysis in the Eye (EAGLE). Treatment of the central retinal artery occlusion: Thrombolysis versus conservative treatment
Final Report Abstract
Central retinal artery occlusion (CRAO) is a serious ophthalmologic disease. The results of conservative treatment vary considerably and although local intraarterial fibrinolysis (UF) is a promising treatment, outcomes have not been compared in randomised trials. Prospective randomised multicenter study by the European Assessment Group for Lysis in the Eye (EAGLE) to compare treatment outcomes of conservative standard treatment (CST) and LIF for acute non-arteritic CRAO. Patients (age 18-75 years) with CRAO not older than 20 h and best-corrected visual acuity (BCVA) < 0 - 5 logMAR were randomised to the CST or LIF groups. Primary endpoint was BCVA after one month; secondary endpoint was safety. Eighty-four patients were recruited (40 CST, 44 LIF) over five years and data for 82 patients were analysed. Mean interval between first symptoms and therapy was 10 99 ± 5 - 49 hours (CST) and 12 78 ± 5 77 hours (LIF). Mean BCVA (logMAR) improved significantly in both groups (CST: - 0.44 [SD 0.55] ; LIF: - 0.45 [SD 0.5.5] ; both p < 0.0001) and did not differ between groups (p = 0-69). Clinically significant visual improvement was noted in 60 % (CST) and 57 - 1 % (UF). Two patients in the CST group (4-3%) and 13 patients in the LIF group (37.1%) had adverse reactions. Because of similar efficacy and the higher rate of adverse reactions in the LIF group the study was stopped after the first interim analysis. In view of similar clinical improvement with both therapies and higher adverse reaction rate after LIF, patients with acute CRAO should undergo CST. This conservative standard treatment should include intravenous bolus iniection of 5000 IU heparin, single intravenous iniection of 500 mg acetazolamide, globe massage (5 minutes), single use of topical beta-blocker, 100 mg acetylsalicylic acid for at least 4 weeks, single isovolaemic hoemodilution (if haematocrit over 40%), weight-adapted low dose heparin twice/d for 5 days.
Publications
- Prognosis of central retinal artery occlusion: Local intraarterial fibrinolysis versus conservative treatment. Am J Neuroradiol 23: 1301-1307 (2002)
Schmidt D, Schulte-Mönting J, Schumacher M
- Retinale arterielle Verschlüsse. Ophthalmologe 100: 651-667 (2002)
Feltgen N, Schmidt D, Hansen LL
- Thrombolysis and angioplasty in special situations. In: J. Byme (ed.) Interventional Neuroradiology, pp 309-329, Oxford University Press (2002)
Schumacher M, Schmidt D
- Lysis therapy vs. conservative therapy: Randomised and prospective study on the treatment of acute central retinal artery occlusion (EAGLE study). Ophthalmologe 103(10): 898-900 (2006)
Feltgen N, Reinhard T, Kampik A, Jurklies B, Brückmann H, Schumacher M
- Multicenter study of the European Assessment Group for Lysis in the Eye (EAGLE) for the treatment of central retinal artery occlusion: design issues and implications. EAGLE Study report no. 1. Graefe's Arch Clin Exp. Ophthalmol 244: 950-956 (2006)
Feltgen N, Neubauer A, Jurklies B, Schmoor C, Schmidt D, Wanke J, Maier-Lenz H, Schumacher M
- Response to comment: Multicenter study of the European Assessment Group for Lysis in the Eye (EAGLE-Group) for the treatment of central retinal artery occlusion: design issues and implications. EAGLE study report no. 1. Graefe's Arch Clin Exp Ophthalmol 245 (3): 464-466 (2007)
Feltgen N, Schmidt D, Schumacher M
- Circadian incidence of non-inflammatory retinol artery occlusions. Online publication Graefes Arch Clin Exp Ophthalmol (2008)
Schmidt D, Schumacher M, Feltgen N
- Retinal vascular occlusions: on interdisciplinary challenge. Dtsch Ärztebl Int. 2008 Jun; 105 (26): 474-9. Epub 2008 Jun 27
Mirshahi A, Feltgen N, Hansen LL, Hattenbach LO
- Central retinal artery occlusion: local intraarterial fibrinolysis versus conservative treatment. A multicentre randomised trial (EAGLE-Study). The Lancet
Schumacher M, Schmidt D, Jurklies B, Gall C, Wanke I, Schmoor C, Maier-Lenz H, Solymosi L, Brückmann H, Neubauer AS, Wolf A, Feltgen N
