Research with human participants

Overview of medical research in the Netherlands

The exploratory use of an experimental flow-OCT instrument in chorioretinal diseases

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Last updated:

To explore and optimize the usability of Doppler-OCT scanning of conditions affecting any of the retino-choroidal layers.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Retina, choroid and vitreous haemorrhages and vascular disorders
Study type
Observational non invasive

ID

NL-OMON43985

Source

ToetsingOnline

Brief title

Exploratory use of experimental flow-OCT

Condition

  • Retina, choroid and vitreous haemorrhages and vascular disorders

Synonym

chorioretinal diseases

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Stichting Wetenschappelijk Onderzoek Oogziekenhuis - SWOO.

Intervention

Keyword :
chorioretinal diseases, diagnostics, Doppler-OCT, non-invasive

Outcome measures

Primary outcome

Hypotheses for further studies (ptotocol 8.1).

Secondary outcome

See paragraph 8.1 of the protocol.

Background summary

Optical Coherence Tomography (OCT) has become the dominant imaging modality for
the posterior eye. New developments, such as the analysis of phase shifts in
the reflected light from the retina to determine depth-resolved blood flow
(Doppler-OCT), appear to be a promising way towards improved diagnostics for a
wide range of ophthalmic conditions.

Study objective

To explore and optimize the usability of Doppler-OCT scanning of conditions
affecting any of the retino-choroidal layers.

Study design

Exploratory, observational.

Study burden and risks

Risks are negligible, inconvenience is minimal. Participants do not benefit. A
study-related visit lasts maximally 30 minutes.

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

Age > 18 yrs.
Informed consent.
The subject must either have no known chorioretinal pathologies (healthy volunteers) or an ophthalmic disease that affects the perfusion or blood flow in the retina or the choroid.

Exclusion criteria

Pupil size (dim ambient light) < 3.0 mm.

Design

Study type :
Observational non invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
100
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
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 NL55220.078.15