Ibopamine 2% eye drops in the treatment of patients with ocular hypotony after vitreoretinal surgery for retinal detachment or uveitis: results after six months of treatment

ISRCTN	ISRCTN46178243
DOI	https://doi.org/10.1186/ISRCTN46178243
Secondary identifying numbers	OZR-2003-16

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Non-randomised trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Ibopamine 2% eye drops in the treatment of patients with ocular hypotony after vitreoretinal surgery for retinal detachment or uveitis: results after six months of treatment
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ocular hypotony following either vitreoretinal surgery or uveitis
Intervention	Long-term topical treatment with Ibopamine (2%) eye drops.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ibopamine
Primary outcome measure	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 study start date	01/03/2004
Completion date	01/03/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	21 (Study closed, analysis & publication in progress)
Total final enrolment	17
Key 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
Key exclusion criteria	1. Chronic heart failure 2. Hypotony caused by other factors than surgery or uveitis 3. Traction on corpus ciliare 4. Cyclodialysis
Date of first enrolment	01/03/2004
Date of final enrolment	01/03/2006

Oogziekenhuis Rotterdam

Rotterdam
3011 BH
Netherlands

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Hospital/treatment centre

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Hospital/treatment centre

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/04/2012	12/04/2021	Yes	No

12/04/2021: Publication reference and total final enrolment added.