OCTA Metrics Repeatability and Reproducibility in Different Disorders

NCT04488887 | Unknown

• 1 other identifier: 33875/6/20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Retinal imaging is a corner stone in diagnosis of most retinal disorders. Standard imaging techniques e.g. fluorescein angiography and color fundus photography have a lot of limitations including limited resolution, invasive nature in cases of fluorescein angiography, and inability to segment the retina, accordingly, and only 2D image is provided. Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities. Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina. Different quantitative metrics has been extracted from enface OCTA images including vessel density, FAZ area, choriocapillaries flow deficit, intercapillary area and fractal dimension. These metrics are helpful in evaluation the retinal perfusion and used by physicians to assess various retinal vascular disorders. Although some previous literatures had discussed the repeatability of OCTA metrics, however, comprehensive evaluation of widely used metrics in various retinal condition has not be done. Additionally, recent data suggest that various methods of calculation of these metrics my yield final different results of the same metric.

Conditions

Diabetic Retinopathy; Myopia; Choroidal Neovascularization; Healthy

Outcome Measures

Primary Outcomes (2)

• The intraclass correlation coefficient (ICC)

  ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (\<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent).

  5 months

• coefficient of variation (CV)

  The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value \<10% represents good repeatability of the measurement.

  5 months

Study Arms (4)

Diabetic retinopathy Group

Patients with non-proliferative and proliferative diabetic retinopathy with clear media will be recruited.

Diagnostic Test: Optical coherence tomography angiography

Myopia Group

Patients with different grades of myopia, with accurate segmentation will be recruited

Diagnostic Test: Optical coherence tomography angiography

Choroidal neovascularization group

Patients with active choroidal vascularization without scarring will be recruited

Diagnostic Test: Optical coherence tomography angiography

Healthy controls

Healthy individuals without retinal disorders will be included for comaprison

Diagnostic Test: Optical coherence tomography angiography

Interventions

Optical coherence tomography angiography DIAGNOSTIC_TEST

patients in all groups will be examined with optical coherence tomography angiography, for every eye 3 macular and 3 papillary scans will be performed by two different OCTA machines, analysis will be carried out to evaluate the repeatability and reproducibility of the test

Choroidal neovascularization group; Diabetic retinopathy Group; Healthy controls; Myopia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Repeatability and reproducibility of the different OCTA metrics will be carried out in the following disorders; diabetic retinopathy, myopia, choroidal neovascularization, and in healthy controls for comparison.

You may qualify if:

• Patients 18 years or above, that fall in any of the study groups
• Clear media allowing for imaging

You may not qualify if:

• Maculopathies (hereditary or acquired)
• Optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
• Optic neuropathies (demyelinating, infectious, ischemic, etc.),
• corneal edema and dense cataracts that can disrupt images
• history of vasoactive agents (calcium antagonists, nitric oxide, etc.)
• systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
• Previous ocular surgery

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ophthalmology Department, Faculty of medicine, Tanta Univeristy

Tanta, 31515, Egypt

Location

Related Publications (2)

• Mehta N, Liu K, Alibhai AY, Gendelman I, Braun PX, Ishibazawa A, Sorour O, Duker JS, Waheed NK. Impact of Binarization Thresholding and Brightness/Contrast Adjustment Methodology on Optical Coherence Tomography Angiography Image Quantification. Am J Ophthalmol. 2019 Sep;205:54-65. doi: 10.1016/j.ajo.2019.03.008. Epub 2019 Mar 15.

  PMID: 30885708 BACKGROUND

• Byon I, Alagorie AR, Ji Y, Su L, Sadda SR. Optimizing the Repeatability of Choriocapillaris Flow Deficit Measurement From Optical Coherence Tomography Angiography. Am J Ophthalmol. 2020 Nov;219:21-32. doi: 10.1016/j.ajo.2020.05.027. Epub 2020 May 23.

  PMID: 32454035 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Myopia; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Refractive Errors; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Osama A Sorour, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rauof A Gaber

CONTACT

+201012292208; dr.osamasorour@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Retina Consultant & the principal investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 28, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)