1, Quantify and compare vascular and structural parameters obtained from AO-FIO, OCTA, OCT, and CFP in both healthy controls and glaucoma patients; 2, Investigate the correlation between these parameters and assess the additional value of vascular…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Inner diameter, outer diameter, parietal thickness, wall cross-sectional
area, and wall-to-lumen ratio (WLR); comparison between glaucoma patients and
healthy controls.
Secondary outcome
n/a
Background summary
Changes resulting in reduced density and caliber of retinal blood vessels are
observed in glaucoma patients. Numerous studies have demonstrated significant
reductions in flow density, flow index, and vessel density in the optic nerve
head and macula among patients with glaucoma. Additionally, these parameters
have shown associations with visual field loss.
The introduction of adaptive optics (AO) in ophthalmic care has resulted in
retinal images with unprecedented cellular resolution. AO allows the evaluation
of individual retinal structures, including blood vessels.
This pilot study aims to evaluate the parameters of retinal arteries in
patients with glaucoma when compared to healthy controls using the rtx1 AO-FIO
camera. Also, we want to investigate the associations between these vascular
parameters and those retrieved from OCT, OCTA, functional defects in the visual
field, and other features important for glaucoma diagnosis such as IOP, CCT,
and iridocorneal angle.
Study objective
1, Quantify and compare vascular and structural parameters obtained from
AO-FIO, OCTA, OCT, and CFP in both healthy controls and glaucoma patients; 2,
Investigate the correlation between these parameters and assess the additional
value of vascular parameters obtained from AO-FIO compared to those retrieved
from OCTA, OCT, CFP, and clinical parameters.
Study design
prospective, observational pilot.
Study burden and risks
risks, none. Burden limited to time.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Glaucoma patients
- Diagnosis of Primary Open-Angle Glaucoma (POAG) at the Rotterdam Eye Hospital.
Healthy controls
- Age-matched with glaucoma subjects.
Exclusion criteria
A potential glaucoma subject who meets any of the following criteria will be
excluded from the study:
1. History of diseases associated to retinal vascular effects (e.g. diabetes,
high blood pressure, cardiovascular disease, ocular inflammation, retinal
degeneration);
2. Smoking at least weekly within the last 5 years;
3. Any ocular abnormalities likely to interfere with scans (e.g., retinal
abnormalities, corneal opacities, moderate to severe cataract, nystagmus);
4. Unable to give informed consent, including age <16 years;
5. Unable to comfortably undergo ocular scans for a total cumulative time of 1
hour (e.g. head and neck mobility issues (including tremors), anxiety, either
mentioned or observed, severe eye irritation, severe ptosis).
6. Refractive error larger than 3 diopters.
Additionally, healthy controls will be excluded if they:
1. Do not have a normal IOP range (10-21mmHg);
2. Have fundus abnormalities;
3. Do have a visual field loss;
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 | NL87556.078.24 |