Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J C van Meurs

ORCID ID

Contact details

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 7777
vanMeurs@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OZR-2001-18; NTR189

Study information

Scientific title

Acronym

Study hypothesis

Intravitreal 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

Received from the local medical ethics committee

Study design

Randomised, double-blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Post-operative bacterial endophthalmitis

Intervention

Intravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Vancomycin, gentamycin, dexamethasone diphosphate

Primary outcome measures

Vision (ETDRS) after 3, 6 and 12 months, panbacterial polymerase chain reaction (PCR).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Post-cataract bacterial endophthalmitis
2. Strong, and increasing, irritation of anterior chamber and/or vitreous during post-operative 8 weeks interval

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150

Participant exclusion criteria

Antibiotics treatment

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Organisation

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)

Sponsor details

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 77 77
info@oogziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes