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-2001-09; NTR194
Study information
Scientific title
Acronym
Study hypothesis
A pre-operative subconjunctival injection of dexamethasone reduces the incidence of proliferative vitreoretinopathy in patients with ablatio retinae.
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
Rhegmatogenous retinal detachment
Intervention
Pre-operative and post-operative subconjunctival injection of dexamethasone (10 mg) or placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Dexamethasone
Primary outcome measures
Incidence of proliferative vitreoretinopathy.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2002
Overall trial end date
22/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary rhegmatogenous retinal detachment
2. No previous ablation surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (Study closed, analysis & publication in progress)
Participant exclusion criteria
1. Diabetes mellitus
2. Systemic steroids
3. Steroid eye drops
4. Steroid glaucoma responder
Recruitment start date
01/11/2002
Recruitment end date
22/01/2005
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20182883
Publication citations
-
Results
Bali E, Feron EJ, Peperkamp E, Veckeneer M, Mulder PG, van Meurs JC, The effect of a preoperative subconjuntival injection of dexamethasone on blood-retinal barrier breakdown following scleral buckling retinal detachment surgery: a prospective randomized placebo-controlled double blind clinical trial., Graefes Arch. Clin. Exp. Ophthalmol., 2010, 248, 7, 957-962, doi: 10.1007/s00417-010-1319-8.