• In this pilot study, PS-OCT is used to image differences in fibrillary ocular structures associated with disease in patients with glaucoma, high myopia, exudative age-related macular degeneration with a suspicion of subretinal fibrosis and…
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) quantification of the amount of variability in fibrosis measurements
calculated from PS-OCT images; the standard deviation of fibrosis volume
measurement needs to be measured within one session in several patients to
determine the sample size and expectations of future research to measure
fibrosis growth.
2) A change to the scleral retinal ring layer around the optic nerve head in
myopia and glaucoma patients when compared to nearly age/sex-matched healthy
volunteers.
3) Measuring the orientation of collagen in the peripapillary sclera in OI
patients.
Secondary outcome
Secondary outcome measures are:
Current diagnostics tools (visual acuity, slit-lamp examination/biomicroscopy,
fundusphotography, standard OCT, eye pressure, axial measurement)
General quality metrics for PS-OCT scans by calculating feature signal-to-noise
ratio and the useful signal penetration depth in the sclera for patients and
healthy volunteers.
Background summary
In ophthalmology the conventional spectral domain optical coherence tomography
(SD-OCT) has become indispensable to examine the retina and optic nerve head.
Recently a prototype was constructed of an integrated polarization-sensitive
optical coherence tomography (PS-OCT) system. This device is expected to add a
new diagnostic dimension with the visualization of changes in retardation in
fibrillary structures of the eye, like the retinal nerve fiber layer (RNFL),
the (peripapillary) sclera, and in subretinal fibrosis associated with wet
age-related macular degeneration (wAMD).
Study objective
• In this pilot study, PS-OCT is used to image differences in fibrillary ocular
structures associated with disease in patients with glaucoma, high myopia,
exudative age-related macular degeneration with a suspicion of subretinal
fibrosis and osteogenesis imperfecta (OI) patients. This will be done by
quantifying the amount of system-induced variability in fibrosis measurements,
and differences in the size of the sclera around the optic nerve head caused by
high myopia and glaucoma patients when compared to nearly age/sex-matched
healthy volunteers. For patients suffering from osteogenesis imperfeca (OI) the
presence of the circularly oriented scleral collagen layer will be measured.
• This study also aims to use collected data to establish quality metrics
applicable to PS-OCT scans.
Study design
This is an exploratory study in which PS-OCT measurements will be performed.
The participants will undergo, after reading and signing of an informed
consent, standard clinical examinations and an examination with the PS-OCT
system. Examination with the PS-OCT will take around an hour. Using the PS-OCT
system, fibrillary structures in the eyes are visualized based on the
reflectivity for orthogonal polarization states in the wavelength range of 1010
to 1110 nm.
Study burden and risks
This is a study, with minimal burden to the participants. The treatment and
treatment duration will not be affected. This study forms a step towards the
establishment of biomarkers of ocular diseases associated with changes in
fibrillary structure and the monitoring of these diseases. The results of this
study can be used to investigate and improve PS-OCT in vivo.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
• Patients with glaucoma, high myopia or exudative AMD
• Healthy participants
• 18 years of age or older
• Willing and able to sign the informed consent, after reading the patient
information form
• Able to maneuver into the ophthalmic devices (in case of wheelchair-bound
type III patients)
• OI patients need to be accompanied by a friend or family member during their
visit
Exclusion criteria
• Media opacities, like cataract, causing unreliable images with the PS-OCT
• Any ocular disease (outside glaucoma/myopia/exudative AMD) with possible
influence on ocular fibrillary structures
• Recent (< 3 months) ocular surgery
Design
Recruitment
Medical products/devices used
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 | NL77059.029.21 |