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, 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
South Korea
Yangsan
50612
Korea
South
82-55-360-2595
jjongggal@naver.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05-2018-145
Study information
Scientific title
Diagnostic Ability of Macular Vessel Density in the Ganglion Cell–Inner Plexiform Layer on Optical Coherence Tomographic Angiography for Glaucoma
Acronym
OCTAGCIPL
Study hypothesis
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.
Ethics approval
Institutional Review Board of Pusan National University Yangsan Hospital, 09/08/2018, ref. 05-2018-145.
Study design
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 below 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
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
01/11/2018
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 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
01/12/2018
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, South Korea
Yangsan
50612
Korea, South
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
01/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list