Condition category
Eye Diseases
Date applied
07/03/2019
Date assigned
28/03/2019
Last edited
25/03/2019
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 (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

Publication citations

Additional files

Editorial Notes

25/03/2019: Trial's existence confirmed by Institutional Review Board.