Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/12/2007
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-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. Patient’s 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

Publication citations

Additional files

Editorial Notes