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?
Jonghoon shin
jjongggal@naver.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Jonghoon Shin
ORCID ID
http://orcid.org/0000-0003-1721-1253
Contact details
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 2595
jjongggal@naver.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
03-2019-001
Study information
Scientific title
Regional relationships between peripapillary vascular density assessed by optical coherence tomographic angiography and visual field sensitivity in glaucoma
Acronym
OCTAPVDVF
Study hypothesis
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.
Ethics approval
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: pnuyhirb@gmail.com, IRB No. 05-2019-005
Study design
Single-center comparative cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Glaucoma
Intervention
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.
Intervention type
Other
Phase
Drug names
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
01/07/2018
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients:
1. Primary open angle glaucoma
2. Undergoing treatment with drugs
Control group:
1. Visited the clinic for regular eye examinations for refractive errors
Participant type
Patient
Age group
Adult
Gender
Both
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
01/08/2018
Recruitment end date
31/01/2019
Locations
Countries of recruitment
Korea, South
Trial participating centre
Pusan National University Yangsan Hospital
20-Geumo-ro, Mulgeum-eup
Yangsan
50612
Korea, South
Sponsor information
Organisation
Pusan National University Yangsan Hospital
Sponsor details
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea
South
+82 (0)55 360 2595
jjongggal@naver.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Pusan National University Hospital
Alternative name(s)
PNUH
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Korea, South
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
30/04/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list