Does a pre-operative subconjunctival injection of dexamethasone reduce the incidence of proliferative vitreoretinopathy in patients with ablatio retinae?

ISRCTN ISRCTN31308983
DOI https://doi.org/10.1186/ISRCTN31308983
Secondary identifying numbers OZR-2001-09; NTR194
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
04/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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 objectivesA pre-operative subconjunctival injection of dexamethasone reduces the incidence of proliferative vitreoretinopathy in patients with ablatio retinae.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedRhegmatogenous retinal detachment
InterventionPre-operative and post-operative subconjunctival injection of dexamethasone (10 mg) or placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dexamethasone
Primary outcome measureIncidence of proliferative vitreoretinopathy.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/11/2002
Completion date22/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 (Study closed, analysis & publication in progress)
Key inclusion criteria1. Primary rhegmatogenous retinal detachment
2. No previous ablation surgery
Key exclusion criteria1. Diabetes mellitus
2. Systemic steroids
3. Steroid eye drops
4. Steroid glaucoma responder
Date of first enrolment01/11/2002
Date of final enrolment22/01/2005

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 Yes No