The Relationship Between Macular OCTA and GCIPL and Their Combinational Index Using AI

NCT03369886 | Unknown

• 1 other identifier: 1708-037-058
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Macular GCIPLT and vessel density will be measured with Spectralis optical coherence tomography and Topcon swept-source OCT respectively. Linear, quadratic and exponential regression models will be used to investigate relationship between GCIPLT and vessel density. Multilayer neural network will bel used to make single combined parameter and the diagnostic performance will be also compared.

Conditions

Angiography; Glaucoma, Open-Angle

Keywords

OCTA; Angiography; Artificial neural network

Outcome Measures

Primary Outcomes (1)

• Vessel density

  Macular vessel density measured by optical coherence tomography angiography

  20 minutes

Study Arms (2)

Early glaucoma group

OTHER

Patients whose visual field mean deviation is \> -6dB OCT angiography will be taken but there are no difference between patients' group. The same OCT angiography protocol will be applied to all patients' group.

Diagnostic Test: Optical Coherence Tomography Angiography (OCTA)

Advanced glaucoma group

OTHER

Patients whose visual field mean deviation is \< -6dB OCT angiography will be taken but there are no difference between patients' group. The same OCT angiography protocol will be applied to all patients' group.

Diagnostic Test: Optical Coherence Tomography Angiography (OCTA)

Interventions

Optical Coherence Tomography Angiography (OCTA) DIAGNOSTIC_TEST

The images will be obtained using a commercial swept-source OCT (SS-OCT) device (DRI OCT Atlantis; Topcon, Tokyo, Japan). SS-OCT uses infrared light, wavelength of 1050 nm which is longer than conventional SD-OCT, at 100,000 A-scans per second. This longer infrared light source has advantages of deep signal penetration through the retina and choroid. Its axial and transversal resolution is 7 and 20 μm in tissue, respectively. Volumetric OCT scans were taken from 6 × 6 mm cubes. Each cube consists of 320 clusters of 4 repeated B-scans centered on the fovea. Moving objects (mostly blood flows) are detected by measuring intensity fluctuations from these repeatedly scanned OCT images. Automated segmentation was performed by OCT software to separate each layer of the retina. The en-face images of the superficial capillary network were derived from an en-face slab, ranged from the internal limiting membrane (ILM) to the inner border of the inner nuclear layer (INL).

Advanced glaucoma group; Early glaucoma group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants were age \> 18 years
• clear cornea and clear ocular media
• BCVA ≥ 20/40
• a refractive error within ± 6.0 diopters (D), and astigmatism ± 3.0 D.

You may not qualify if:

• History of diabetes, uveitis, secondary glaucoma
• corneal abnormalities, non-glaucomatous optic neuropathies
• Previous ocular trauma
• Previous ocular surgery or laser treatment,
• Any other eye disease except for glaucoma

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49214, South Korea

RECRUITING

Related Publications (3)

• Leveque PM, Zeboulon P, Brasnu E, Baudouin C, Labbe A. Optic Disc Vascularization in Glaucoma: Value of Spectral-Domain Optical Coherence Tomography Angiography. J Ophthalmol. 2016;2016:6956717. doi: 10.1155/2016/6956717. Epub 2016 Feb 22.

  PMID: 26998352 RESULT

• Rao HL, Pradhan ZS, Weinreb RN, Riyazuddin M, Dasari S, Venugopal JP, Puttaiah NK, Rao DA, Devi S, Mansouri K, Webers CA. A comparison of the diagnostic ability of vessel density and structural measurements of optical coherence tomography in primary open angle glaucoma. PLoS One. 2017 Mar 13;12(3):e0173930. doi: 10.1371/journal.pone.0173930. eCollection 2017.

  PMID: 28288185 RESULT

• Suh MH, Zangwill LM, Manalastas PI, Belghith A, Yarmohammadi A, Medeiros FA, Diniz-Filho A, Saunders LJ, Weinreb RN. Deep Retinal Layer Microvasculature Dropout Detected by the Optical Coherence Tomography Angiography in Glaucoma. Ophthalmology. 2016 Dec;123(12):2509-2518. doi: 10.1016/j.ophtha.2016.09.002. Epub 2016 Oct 18.

  PMID: 27769587 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 subject groups: 1. Normal control: Subjects who has normal fundus, normal visual field and normal intraocular pressure. 2. Early glaucoma: : Patients who shows glaucomatous visual field abnormality but visual field mean deviation is \> -6 dB 3. Advanced glaucoma : Patients who shows glaucomatous visual field abnormality but visual field mean deviation is \< -6 dB

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: September 25, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Sharing will be started from 31 August 2018 (anticipated) for 2 years.
• Access Criteria: Data will be shared on request (contact email: climyth@naver.com)

Locations

KR (1)