The purpose of this study is to identify and quantify the influence of medium opacity on RNFL and inner retinal layer thickness measurements using SD-OCT, as well as the effect of cataract on the filter measurements. Also to evaluate theā¦
ID
Source
Brief title
Condition
- Other condition
- Glaucoma and ocular hypertension
Synonym
Health condition
oogaandoeningen, staar
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of measured layer thickness decrease in retinal layer thickness
measurements, induced by the increase in optical density of the artificial
filters.
The relationship between the underestimation of the retinal layer thicknesses
and the optical density of the artificial filters.
The relationship between these filter measurements before and after cataract
surgery.
The difference in measured RNFL thickness between volume scans and
peripapillary circle scans of the optic nerve head.
Secondary outcome
NA
Background summary
Optical coherence tomography (OCT) is an objective imaging technique, based on
coherence interferometry.1 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
OCT is non-invasive technique and just lightly burdensome for patients. It only
takes a few seconds to acquire the images and the whole procedure takes a few
minutes, dependant on the amount of scans required.
Retinal nerve fiber layer (RNFL) thickness measurements are one of the OCT
measurements that have shown good reproducibility and good diagnostic abilities
for the diagnosis of primary open angle glaucoma. Thickness measurement of the
macular inner retinal layer in the macular region has also shown promise as
diagnostic measurement for the detection of glaucoma.
Previous studies have demonstrated that RNFL thickness measurements are
influenced by cataract. A linear relationship has been described between
OCT-equivalent optical density of cataract and underestimation of RNFL
thickness measured with OCT.
We aim to identify and quantify the influence of artificial filters with a
predefined optical density on retinal nerve fiber layer (RNFL) measurements,
and inner retinal layers using spectral domain optical coherence tomography
(SD-OCT), as well as the effect of cataract on the filter measurements.
RNFL thickness measurements with SD-OCT can be done using different scan
protocols. Most SD-OCT instruments feature a 3D data set protocol and circular
scan protocol. We intend to evaluate the reproducibility and agreement of two
SD-OCT scan protocols for RNFL thickness layer measurements.
Study objective
The purpose of this study is to identify and quantify the influence of medium
opacity on RNFL and inner retinal layer thickness measurements using SD-OCT, as
well as the effect of cataract on the filter measurements.
Also to evaluate the reproducibility and agreement of two different SD-OCT scan
protocols for RNFL thickness layer measurements
Study design
A cross sectional study involving healthy subjects, glaucoma and cataract
patients
Study burden and risks
Participants of this study will not be exposed to invasive methods. The study
will require time of the patients. 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
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria healthy volunteers
* Willing and able to sign the informed consent, after reading the information form
* No history of ophthalmological disease;Glaucoma patients:
* Willing and able to sign the informed consent, after reading the information form
* Diagnosed with primary open angle glaucoma;Cataract patients:
* Willing and able to sign the informed consent, after reading the information form
* Diagnosed with cataract and eligible for cataract surgery
Exclusion criteria
For healthy volunteers and glaucoma patients
* 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-8 dioptres
* Presence of diseases including retinal disorders that may influence visual acuity, visual field testing or the results of structural measurements done by SD-OCT;For cataract patients:
* Media opacities other than cataract, that will make it impossible to make reliable images with the OCT
* Hypermetropia more than S+5 dioptres, or myopia more than S-8 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
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 | NL40286.018.12 |