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-2003-16
Study information
Scientific title
Acronym
Study hypothesis
Long-term administration of Ibopamine hydrochloride eye drops restores and maintains intraocular pressure in patients with hypotony following vitreoretinal surgery for ablatio reinae, or uveitis.
Ethics approval
Not provided at time of registration
Study design
Non-randomised trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Ocular hypotony following either vitreoretinal surgery or uveitis
Intervention
Long-term topical treatment with Ibopamine (2%) eye drops.
Intervention type
Drug
Phase
Not Specified
Drug names
Ibopamine
Primary outcome measures
1. Ocular pressure
2. Vision
Secondary outcome measures
1. Position of silicone oil (after surgery)
2. Patients comfort/pain five minutes after eye drops administration
Overall trial start date
01/03/2004
Overall trial end date
01/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Hypotony (0-5 mm Hg)
2. Stable eye pressure for at least 4 months
3. No reaction of eye pressure to atropine and steroids
4. Continued steroid treatment during past six months
5. Status after vitreoretinal surgery or uveitis
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
21 (Study closed, analysis & publication in progress)
Participant exclusion criteria
1. Chronic heart failure
2. Hypotony caused by other factors than surgery or uveitis
3. Traction on corpus ciliare
4. Cyclodialysis
Recruitment start date
01/03/2004
Recruitment end date
01/03/2006
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
Hospital/treatment centre
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