Plain English Summary
Background and study aims
The development of optical coherence tomography (OCTA) has enabled non-invasive measurements of vascular changes in the retinal layers, and this new tool has been increasingly used in retinal diseases and glaucoma. Several previous studies have investigated the vessel density in the peripapillary area or parafoveal region with OCTA in patients with glaucoma. Some of these studies have shown that the abnormal vessel density in OCTA has a significant association with glaucomatous optic nerve damage, although it has been controversial whether these abnormal vascular densities in glaucoma are the primary cause of the disorder or secondary changes due to the disorder.
With the recent developments in OCTA software, it is possible to segment the macular vessel density and to measure the vessel density layer-by-layer. Therefore, in this study, we will analyse the macular vessel density layer-by-layer and compared the diagnostic ability of each for detection of glaucoma.
Who can participate?
Patiens with primary open angle glaucoma undergoing treatment with drugs and patients visiting the clinic for regular eye examinations for refractive errors.
What does the study involve?
All participants will be investigated using macular optical coherence tomographic angiography, fundus photography, and 24-2 visual field
What are the possible benefits and risks of participating?
Since this study is observational and evaluating the diagnostic value of OCTA in glaucoma, we expect that there are no benefits or risks to the participants.
Where is the study run from?
Glaucoma clinic in pusan national university Yangsan hospital, Yangsan, South Korea
When is the study starting and how long is it expected to run for?
February 2019 until February 2020
Who is funding the study?
Pusan National University Yangsan Hospital
Who is the main contact?
Jonghoon shin, firstname.lastname@example.org
Diagnostic Ability of Macular Vessel Density in the Ganglion Cell–Inner Plexiform Layer on Optical Coherence Tomographic Angiography for Glaucoma
Some previous studies have shown that the abnormal vessel density in OCTA has a significant association with glaucomatous optic nerve damage, although it has been controversial whether these abnormal vascular densities in glaucoma are the primary cause of the disorder or secondary changes due to the disorder. In addition, with the recent developments in OCTA software, it is possible to segment the macular vessel density and to measure the vessel density layer-by-layer.
We will use optical coherence tomographic angiography to compare the diagnostic ability of measuring abnormal vessel density vs layer-by-layer macular vessel density for detection of glaucoma.
Institutional Review Board of Pusan National University Yangsan Hospital, 09/08/2018, ref. 05-2018-145.
comparative cross-sectional study
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
All participants underwent the following ophthalmic examinations
1. BCVA measurements, slit-lamp examination, gonioscopy, and IOP measurement with the Goldmann applanation tonometer.
2. Red-free fundus photography using a non-mydriatic fundus camera (Canon CR-2, Canon, Tokyo, Japan)
3. OCTA measurements using Topcon Atlantis (DRI OCT-1, Topcon, Tokyo, Japan)
4. Automated visual field examination using the Humphrey 740 Visual Field Analyzer (Carl Zeiss Meditec, Dublin, CA, USA) were performed on all subjects.
Glaucoma patients should keep using the glaucoma treatment with topical IOP-lowering agents, and age-matched normal controls who visited our clinic for regular eye examinations for refractive errors.
Primary outcome measure
The macular vessel density is measured using optical coherence tomographic angiography at the retinal nerve fiber–ganglion cell–inner plexiform layer, retinal nerve fiber–ganglion cell layer, retinal nerve fiber layer, ganglion cell–inner plexiform layer, ganglion cell layer, and inner plexiform layer segments.
Secondary outcome measures
The macular vessel densities in six segments are compared between glaucoma patients and normal controls.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Primary open angle glaucoma
2. Undergoing treatment with drugs
1. Visited the clinic for regular eye examinations for refractive errors
Target number of participants
over fifty participants per group
Participant exclusion criteria
1. Best-corrected visual acuity less than 20/40
2. Refractive error outside the range of – 6.0 to + 3.0 diopters
3. Astigmatism beyond ± 3.0 diopters
4. Previous ocular trauma
5. Ocular surgery or laser treatment
6. History of ocular or systemic disease that could affect the optic nerve or visual field
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Pusan National University Yangsan Hospital
20-Geumo-ro, Mulgeum-eup, Yangsan, South Korea
Pusan National University Hospital
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in the journal Ophthalmology, American Journal of Ophthalmology or JAMA Ophthalmology.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)