Intravitreal dexamethasone treatment of bacterial endophthalmitis

ISRCTN ISRCTN77234772
DOI https://doi.org/10.1186/ISRCTN77234772
Secondary identifying numbers OZR-2001-18; NTR189
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
05/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J C van Meurs
Scientific

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone +31 (0)10 401 7777
Email vanMeurs@oogziekenhuis.nl

Study information

Study designRandomised, double-blind, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesIntravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg reduces tissue damage in patients with bacterial endophthalmitis.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedPost-operative bacterial endophthalmitis
InterventionIntravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg or placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Vancomycin, gentamycin, dexamethasone diphosphate
Primary outcome measureVision (ETDRS) after 3, 6 and 12 months, panbacterial polymerase chain reaction (PCR).
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/01/2003
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants150
Key inclusion criteria1. Post-cataract bacterial endophthalmitis
2. Strong, and increasing, irritation of anterior chamber and/or vitreous during post-operative 8 weeks interval
Key exclusion criteriaAntibiotics treatment
Date of first enrolment01/01/2003
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Hospital/treatment centre

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone +31 (0)10 401 77 77
Email info@oogziekenhuis.nl
ROR logo "ROR" https://ror.org/02hjc7j46

Funders

Funder type

Research organisation

Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan