The role of angiography in glaucoma
| ISRCTN | ISRCTN77990418 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77990418 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 03-2019-001 |
| Sponsor | Pusan National University Yangsan Hospital |
| Funder | Pusan National University Hospital |
- Submission date
- 07/03/2019
- Registration date
- 28/03/2019
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
20-Geumo-ro, Mulgeum-eup
Yangsan
50612
Korea, South
 ORCID ID |
0000-0003-1721-1253 |
|---|---|
| Phone | +82 (0)55 360 2595 |
| jjongggal@naver.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center comparative cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Regional relationships between peripapillary vascular density assessed by optical coherence tomographic angiography and visual field sensitivity in glaucoma |
| Study acronym | OCTAPVDVF |
| Study objectives | 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(s) | 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 |
| 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(s) |
Measured at a single examination: |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| 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 | 01/08/2018 |
| Date of final enrolment | 31/01/2019 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Yangsan
50612
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/05/2020 | 18/02/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/02/2022: Publication reference added.
25/03/2019: Trial's existence confirmed by Institutional Review Board.
