Optical Coherence Tomography Angiography in Myopic Patients

Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Diagnostic test: Optical coherence tomography angiography OCTA

Detailed Description

High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the retina leads to sight threatening complications.

Quantitative measurements of retinal vasculature in the healthy eye have been reported using several in vivo and in vitro techniques, including confocal microscopy, fluorescein angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited from the outpatient clinic of ophthalmology department of El-Minia university hospital.They were divided into two groups, group A included 25 normal eyes of 25 patients. Group B included 50 myopic eyes of 30 patients.

All patients subjected to history taking and full ophthalmological examination in addition to axial length measurment before performing OCTA.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • Minya, Minia, Egypt, 61111
      • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Groiup A patients were chosen when met the inclusion criteria. Group B individuals were chosen among healthy age-matched controls.

Description

Inclusion Criteria:

• • Highly myopic subjects, defined as those with spherical equivalents (SEs) of -6 or more, with axial length greater than 26.5 mm.

Group B individuals were chosen among healthy age-matched controls.

Exclusion Criteria:

• • Patients younger than 18 years old, or older than 45 years.

  • Any patient with macular pathology (e.g. diabetic retinopathy, hypertensive retinopathy, dystrophy)
  • Myopic patients with any vitro-retinal abnormalities (e.g. choroidal neovascular membrane (CNVM), foveoschisis,macular hole)
  • Patients who underwent previous intra ocular surgical procedures.
  • Patients with previous history of intraocular injections.
  • Glaucomatous patients.

Exclusion criteria to the images that has been captured:

• - Low signal strength index (less than 50).
• - Presence of blink artefacts.
• - Poor fixation leading to motion or doubling artefacts.
• - Media opacity obscuring view of the vasculature.
• - Segmentation error due to cystoid macular oedema or epi-retinal membrane, among others.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; Healthy individuals of age-matched	Diagnostic test: Optical coherence tomography angiography OCTA; Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA; Other Names: OCTA
Myopic patients; Patients with myopia who meet the inclusion criteria	Diagnostic test: Optical coherence tomography angiography OCTA; Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA; Other Names: OCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in angiography between the 2 groups	The difference of the volumetric data generated automatically from the OCTA machine at the 3 levels, (the inner retina, outer retina and the choriocapillaris) in three zones (the fovea, the parafovea and the whole image)	through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: M. Tarek A Mosutafa, MD, Lecturer of ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 19, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Myopia; Angiography
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 68-7/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No