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Intravitreal Dexamethason treatment of bacterial endophthalmitis.


- candidate number0
- NTR NumberNTR189
- ISRCTNISRCTN77234772
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsOZR-2001-18 
- Public TitleIntravitreal Dexamethason treatment of bacterial endophthalmitis.
- Scientific TitleIntravitreal Dexamethason treatment of bacterial endophthalmitis.
- ACRONYMN/A
- hypothesisIntravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethason diphosphate 400 mg reduces tissue damage in patients with bacterial endophthalmitis.
- Healt Condition(s) or Problem(s) studiedPostoperative bacterial endophthalmitis
- Inclusion criteria1. Post-cataract bacterial endophthalmitis;
2. Strong, and increasing, irritation of anterior chamber and/or vitreous during postoperative 8 weeks interval.
- Exclusion criteriaAntibiotics treatment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-jun-2011
- Target number of participants150
- InterventionsIntravitreal injection of 400 ėg examethason or placebo.
- Primary outcomeVision (ETDRS) after 3, 6 and 12 months, panbacterial PCR.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsLindstedt EW, Bennebroek CA, van der Werf DJ, Veckeneer M, Norel AO, Nielsen CC, Wubbels RJ, van Dissel JT, van Meurs JC. A prospective multicenter randomized placebo-controlled trial of dexamethasone as an adjuvant in the treatment of postoperative bacterial endophthalmitis: interim safety analysis of the study drug and analysis of overall treatment results. Graefes Arch Clin Exp Ophthalmol. 2014; 252(10): 1631-1637.

Manning S et al. A prospective multi-centre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics. Acta Ophthalmol. Accepted for publication.
- Brief summaryN/A
- Main changes (audit trail)27-jan-2016: status aangepast-EB
- RECORD6-sep-2005 - 22-okt-2017


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