Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/07/2014
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 4017777
vanMeurs@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OZR-2004-06; NTR185

Study information

Scientific title

Acronym

HSO-Study

Study hypothesis

Efficacies of heavy silicone oil and of standard silicone oil, as long-term vitreous tamponade in patients with complex ablatio retinae, are equivalent.

Ethics approval

Ethics approval received from the local medical ethics committee before participants were recruited

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Retinal detachment, proliferative vitreoretinopathy

Intervention

Randomised to:
1. Heavy silicone oil, or
2. Standard silicone oil
As long-term vitreous tamponade.

Intervention type

Drug

Phase

Not Specified

Drug names

Heavy silicone oil, standard silicone oil

Primary outcome measures

Complete retinal reattachment and Early Treatment Diabetic Retinopathy Study (ETDRS) vision after 12 months.

Secondary outcome measures

Number of resurgeries within 12 months

Overall trial start date

01/05/2005

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ablatio retinae with proliferative vitreoretinopathy (PVR)
2. Giant tear below 10 - 12 hours

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Defects above 10 - 12 hours
2. Proliferative diabetic retinopathy
3. Trauma
4. Uveitis
5. Glaucoma
6. Monoculus

Recruitment start date

01/05/2005

Recruitment end date

01/05/2007

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

Publication citations

Additional files

Editorial Notes