We want to assess the diagnostic performance of retinal nerve fiber layer (RNFL) thickness, macular ganglion cell layer (GCL) thickness, lamina cribrosa thickness and choroid thickness around the optic disc measured with SD-OCT in differentiating…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of the new SD-OCT parameters will be compare with
the sensitivity and specificity of the RNFL thickness measurements and the
visual field testing. We will investigate to what extent these new parameters
can contribute in differentiating patients from healthy controls, between
stages of glaucoma, between patients with a normal and an elevated baseline
IOP, and to establish the accuracy to detect progression of glaucoma.
Secondary outcome
- visual acuity
- intra ocular pressure
- visual field test outcome
- RNFL thickness
- GCL thickness
- lamina cribrosa thickness
- peripapillary choroid thickness
Background summary
Primary open angle glaucoma (POAG) is a gradually progressive optic neuropathy,
resulting in irreversible visual field loss. POAG is accompanied by dysfunction
and apoptosis of retinal ganglion cells, whose axons make up most of the
retinal nerve fibre layer (RNFL). The standard test for progression, on which
most treatment decisions are based, is the VF examination. A disadvantage of VF
testing is the fact that it is subjective, and is not particular sensitive for
the earliest changes in glaucoma.
Optical Coherence Tomography (OCT) is an objective imaging technique, based on
coherence interferometry. Spectral domain (SD) OCT, also known as Fourier
Domain OCT, allows fast acquisition of images with high resolution, and with
SD-OCT one can make very accurate measurements.
Studies have shown that RNFL measurements are highly correlated with visual
function. More importantly it has been demonstrated that up to 25 to 35 % of
RNFL thickness is lost before visual field (VF) defects can be detected.(1) It
is estimated that this so called pre-perimetric phase can last up to 5 years.
Recently some new measurements with SD-OCT have been investigated that show
promise in the diagnostic evaluation of glaucoma patients. These are thickness
measurements of the ganglion cell layer, the lamina cribrosa and the
peripapillary choroid.
It is relevant for clinical practice to determine how these new structural
SD-OCT measurements, either as single measurement or in combination, perform in
the diagnosis of different stages of POAG, compared to functional testing. Also
relevant is to know how these measurements differentiate between glaucoma
patients with a normal and with an elevated baseline IOP, and how sensitive
these measurements are to detect progression over time.
Study objective
We want to assess the diagnostic performance of retinal nerve fiber layer
(RNFL) thickness, macular ganglion cell layer (GCL) thickness, lamina cribrosa
thickness and choroid thickness around the optic disc measured with SD-OCT in
differentiating patients from healthy controls, between stages of glaucoma,
between patients with a normal and an elevated baseline IOP, and to establish
the accuracy to detect progression of glaucoma.
The new parameters could add to an improved, earlier diagnosis of glaucoma, and
shed light on the pathophysiologic differences between patients with a normal
or higher baseline eye pressure.
Study design
This study is a multicenter cross-sectional and follow up study involving
glaucoma patients and healthy subjects.
After signing informed consent, participating patients will be included in each
of the following categories, based on the Hodapp classification: ocular
hypertension, suspect glaucoma, early glaucoma and moderate glaucoma.
Based on intra ocular pressure (IOP) day curves before any kind of treatment,
patients in each of the glaucoma category will also be divided in subgroups of
normal tension glaucoma and high pressure glaucoma. For baseline IOP the
highest documented IOP without treatment is taken.
All patients and healthy controls will undergo a complete ophthalmologic
examination, including best-corrected visual acuity, eye pressure measurement
and slit-lamp examination, including gonioscopy.
RNFL thickness, GCL thickness, lamina cribrosa, and peripapillary choroid
thickness will be measured using SD-OCT (Spectralis, Heidelberg). Visual field
testing will be performed using the Humphrey Field Analyzer (HFA), Swedish
Interactive Thresholding Algorithm (SITA) standard 24-2 perimetry. Age, gender,
family history of glaucoma, duration of ocular hypertension, suspect or other
category of glaucoma will be recorded.
Study burden and risks
Participants of this study will not be exposed to invasive methods. The study
will require more time of patients than a regular check-up. Furthermore
mydriatic drops will be instilled that can temporarily cause a slight decrease
in vision. In rare cases an allergic reaction can occur, which can temporarily
cause redness of the eye.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• Patients with ocular hypertension, suspect glaucoma, early glaucoma and moderate glaucoma, 18 years of age or older
• Patients with open anterior chamber angle
• VA > 20/30
• Able to perform reliable visual field test
• Willing and able to sign the informed consent.
Exclusion criteria
• Media opacities, like cataract, that will make it impossible to make reliable images with the OCT
• Hypermetropia more than S+5 dioptres, or myopia more than S-7 dioptres
• Presence of other diseases including retinal disorders that may influence visual acuity, visual field testing or the results of structural measurements done by SD-OCT
• Presence of signs of secondary glaucoma such as inflammatory or neovascular causes, with the exception of pigment dispersion syndrome and pseudoexfoliation syndrome
Design
Recruitment
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 | NL39425.018.12 |