The aim of this study is to explore the capability of the RFI to measure short and long term changes in retinal blood flow velocity and oximetry maps before and after a BGI and to compare these results with OCTA measurements.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood flow at baseline and 3 months after BGI.
Secondary outcome
OCTA measurements
IOP
Background summary
There is increasing evidence that ocular blood flow impairment contributes to
the progression of glaucomatous damage. One of the most frequent surgical
treatments for open angle glaucoma is the Baerveldt Glaucoma Implant (BGI). It
is conjectured that both the presence of the device (by its mechanical effect
on the eye) together with the reduction of intraocular pressure may affect
retinal hemodynamics. The retinal function imager (RFI) allows the measurement
of retinal blood flow velocity and oximetry. With this device, it will be
attempted to determine short and long term changes in the microvascular
condition of patients who receive a BGI. These measurements will be compared to
the results that are obtained with optical coherence tomography angiography
(OCTA).
Study objective
The aim of this study is to explore the capability of the RFI to measure short
and long term changes in retinal blood flow velocity and oximetry maps before
and after a BGI and to compare these results with OCTA measurements.
Study design
Prospective, observational, single center study.
Study burden and risks
Risks are negligible. Patients do not benefit from participation. Study visits
will be combined with regular clinical visits. Extra study related time is
approximately 2 X 1.5 hours (total 3 hours).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Diagnosed high IOP (IOP > 23 mm Hg and <= 40 mm Hg).
18 to 75 years of age.
BCVA of 0.3 or better
Refractive error between -5 and +5 D.
Clear media.
Exclusion criteria
History of atrial fibrillation, atrial flutter, or cardiac pacemaker.
Alcohol, smoking and coffee are not allowed from at least 8 hours before measurements.
Previous intraocular surgery, except uncomplicated cataract extraction > 12 months ago
Evidence of an ocular disease, other than glaucoma or cataract that might interfere with the measurements.
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 | NL64383.078.17 |