Research with human participants

Overview of medical research in the Netherlands

The Vitreous Wipe. Clinical evaluation of an investigational medical device.

Published:
Last updated:

To establish the proportion of complete vitreoschisis removal with PVA.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Retina, choroid and vitreous haemorrhages and vascular disorders
Study type
Interventional

ID

NL-OMON46076

Source

ToetsingOnline

Brief title

Vitreous wipe.

Condition

  • Retina, choroid and vitreous haemorrhages and vascular disorders

Synonym

Retinal detachment (or other damage)

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Vooralsnog geen financiele ondersteuning;hoofdonderzoeker staat garant voor kosten.

Intervention

Keyword :
Iatrogenic retinal damage, Polyvinyl alcohol, Vitrectomy, Vitreoschisis

Outcome measures

Primary outcome

Completeness of vitreoschisis removal, as visualised with triamcinolone,

intraoperatively.

Secondary outcome

Visual outcome, compications.

Background summary

Vitreoschisis causes retinal traction with a high risk of retinal damage.
Therefore, it should be completely removed from the retinal surface. Existing
equipment for vitreoschisis removal involve a substantial risk of iatrogenic
retinal damage. It is conjectured that polyvinyl alcohol (PVA) comprises a safe
and efficient alternative tool for removing vitreoschisis.

Study objective

To establish the proportion of complete vitreoschisis removal with PVA.

Study design

Prospective proof of concept (single-surgeon).

Intervention

Removing vitreoschisis with the Vitreous Wipe.

Study burden and risks

Unremoved vitreoschisis appears to be associated with retinal detachment after
vitrectomy. Compared to existing instruments for vitreoschisis removal, the
Vitreous Wipe is conjectured to reduce the risk of retinal (re-)detachment. No
extra visits are required. Exclusively study related assessments will take
approximately 3 hour extra time.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Informed consent. (If vitreoschisis is positively identified intraoperatively, subject agrees with the use of the Vitreous Wipe.)
Age * 18 years.

Exclusion criteria

Previous vitrectomy.
Tractional retinal detachment.
Proliferative retinal vascular disease.
Proliferative vitreoretinopathy.

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
20
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL65546.078.18