Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/11/2010
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-2001-09; 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

  1. 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.

Additional files

Editorial Notes