Research with human participants

Overview of medical research in the Netherlands

Polarization-sensitive optical coherence tomography
for imaging of the retinal nerve fiber layer

Published:
Last updated:

To assess polarization-related RNFL characteristics of normal and glaucomatous eyes, and to explore the perspective of PS-OCT for other ocular conditions.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Glaucoma and ocular hypertension
Study type
Observational non invasive

ID

NL-OMON45625

Source

ToetsingOnline

Brief title

The RNFL on PS-OCT

Condition

  • Glaucoma and ocular hypertension

Synonym

glaucoma

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Stichting Wetenschappelijk Onderzoek Oogziekenhuis & Rotterdamse Stichting Blindenbelangen

Intervention

Keyword :
OCT, polarization, retinal tissue layers

Outcome measures

Primary outcome

Birefringence and retardation of RNFL.

Secondary outcome

Age, gender etc.

Background summary

The retinal nerve fiber layer (RNFL) has unique polarization properties which
can be measured and quantified by polarization sensitive OCT (PS-OCT). These
properties are induced by the microtubules in the ganglion cell axons. It is
hypothesized that the microtubule density is related to the RNFL*s health and
is affected in glaucoma before actual thinning of the RNFL occurs. Measuring
polarization properties of the RNFL could therefore provide information on
glaucomatous damage at an early stage. Polarization characteristics of other
retinal tissue will be explored for various ocular conditions as well.

Study objective

To assess polarization-related RNFL characteristics of normal and glaucomatous
eyes, and to explore the perspective of PS-OCT for other ocular conditions.

Study design

Prospective, observational.

Study burden and risks

Inconvenience is minimal and risks are considered to be negligible.
Study-related extra time for glaucoma patients and healthy volunteers is 20
minutes, and 40 minutes for patients with other ocular conditions.

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
Age * 18 years

Exclusion criteria

Healthy volunteers:
- Any ocular morbidity except correction of refractive error (CoRE).
Glaucoma patients:
- Any ocular morbidity except CoRE or glaucoma.
Patients with other ocular condition:
- Glaucoma.
- Obstruction of optical pathway (e.g. severe cataract).

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 :
250
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 NL60255.078.16