Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/11/2008
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-2002-17; NTR187

Study information

Scientific title

Acronym

Study hypothesis

Administration of Ibopamine hydrochloride eye drops restores intraocular pressure in patients with hypotony following vitreoretinal surgery or uveitis.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, single blinded, placebo controlled, crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Ocular hypotony following either vitreoretinal surgery or uveitis

Intervention

Treatment with ibopamine hydrochloride (0.5 % or 2%) eye drops or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Ibopamine hydrochloride

Primary outcome measures

Ocular pressure on treatment day

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hypotony (0 - 5 mmHg)
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

Adult

Gender

Both

Target number of participants

15 (study completed)

Participant exclusion criteria

1. Chronic heart failure
2. Traction on corpus ciliare
3. Cyclodialysis

Recruitment start date

01/01/2003

Recruitment end date

01/04/2003

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16490513

Publication citations

  1. Results

    Ugahary LC, Ganteris E, Veckeneer M, Cohen AC, Jansen J, Mulder PG, van Meurs JC, Topical ibopamine in the treatment of chronic ocular hypotony attributable to vitreoretinal surgery, uveitis, or penetrating trauma., Am. J. Ophthalmol., 2006, 141, 3, 571-573, doi: 10.1016/j.ajo.2005.09.034.

Additional files

Editorial Notes