The diagnostic ability of angiography in glaucoma

ISRCTN	ISRCTN23256541
DOI	https://doi.org/10.1186/ISRCTN23256541
Secondary identifying numbers	05-2018-145

Submission date: 02/01/2019
Registration date: 23/01/2019
Last edited: 25/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Jonghoon Shin
Scientific

20-Geumo-ro, Mulgeum-eup, Yangsan, South Korea
Yangsan
50612
Korea, South

ORCID ID	0000-0003-1721-1253
Phone	82-55-360-2595
Email	jjongggal@naver.com

Study information

Study design	comparative cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a participant information sheet
Scientific title	Diagnostic Ability of Macular Vessel Density in the Ganglion Cell–Inner Plexiform Layer on Optical Coherence Tomographic Angiography for Glaucoma
Study acronym	OCTAGCIPL
Study objectives	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(s)	Institutional Review Board of Pusan National University Yangsan Hospital, 09/08/2018, ref. 05-2018-145.
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2018
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	over fifty participants per group
Key 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
Key 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
Date of first enrolment	01/12/2018
Date of final enrolment	31/01/2019

Locations

Countries of recruitment

Korea, South

Study participating centre

Pusan National University Yangsan Hospital

20-Geumo-ro, Mulgeum-eup, Yangsan, South Korea
Yangsan
50612
Korea, South

Sponsor information

Pusan National University Yangsan Hospital
Hospital/treatment centre

20-Geumo-ro, Mulgeum-eup, Yangsan, South Korea
Yangsan
50612
Korea, South

"ROR"	https://ror.org/04kgg1090

Funders

Funder type

Hospital/treatment centre

Pusan National University Hospital
Private sector organisation / Other non-profit organizations

Alternative name(s): PNUH
Location: Korea, South

Results and Publications

Intention to publish date	01/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in the journal Ophthalmology, American Journal of Ophthalmology or JAMA Ophthalmology.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

25/01/2019: Internal review.