Plain English Summary
Background and study aims
The development of optical coherence tomography (OCTA) has enabled non-invasive measurements of vascular (blood vessel) changes in the retinal layers of the eye, 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, and peripapillary vascular density was associated with the severity of visual field damage. However, it remains unknown whether there are significant regional relationships between the peripapillary vascular density and visual field sensitivity. Therefore, the aim of this study is to analyze regional relationships between peripapillary vascular density assessed by optical coherence tomographic angiography and visual field sensitivity in primary open angle glaucoma at different stages and normal eyes. The researchers will investigate relationships between peripapilllary vascular density and visual field sensitivity and compare the diagnostic ability of each for the detection of glaucoma.
Who can participate?
Glaucoma patients and healthy volunteers
What does the study involve?
The study does not involve any interventions, the participants just underwent an eye examination including fundus photo, visual field test, and OCTA.
What are the possible benefits and risks of participating?
As this study doesn't include any interventions no benefits or risks are expected.
When is the study starting and how long is it expected to run for?
July 2018 to December 2019
Who is funding the study?
Pusan National University Hospital (South Korea)
Who is the main contact?
Regional relationships between peripapillary vascular density assessed by optical coherence tomographic angiography and visual field sensitivity in glaucoma
Some previous studies have shown that reduced peripapillary vascular density was reported in glaucomatous eyes, and peripapillary vascular density was associated with the severity of visual field damage. However, it remains unknown whether there are significant regional relationships between peripapillary vascular density and visual field sensitivity. Therefore, in this study, the researchers will analyze regional relationships between peripapillary vascular density assessed by optical coherence tomographic angiography and visual field sensitivity in primary open angle glaucoma at different stages and normal eyes.
Approved 07/01/2019, Institutional Review Board of Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, South Korea, Tel: +82 (0)55 360 3854, Email: email@example.com, IRB No. 05-2019-005
Single-center 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 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
Measured at a single examination:
1. Microvascular images and peripapillary vascular density measured using optical coherence tomographic angiography
2. Visual field sensitivity obtained by automated visual field examination using the Humphrey 740 Visual Field Analyzer
Secondary outcome measures
The diagnostic abilities of the peripapillary vascular density and RNFL thickness for differentiating the control group and glaucoma group (total, mild, moderate-severe subgroups), measured at a single examination
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 50 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
Pusan National University Yangsan Hospital
+82 (0)55 360 2595
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)