Condition category
Eye Diseases
Date applied
02/01/2019
Date assigned
23/01/2019
Last edited
25/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Pusan National University Yangsan Hospital

Sponsor details

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

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

01/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/01/2019: Internal review.