Optical Coherence Tomography Angiography in Myopic Patients

NCT04135209 | Completed

• 1 other identifier: 68-7/2018
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Keywords

Optical coherence tomography; Angiography; Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy controls

Healthy individuals of age-matched

Diagnostic Test: Optical coherence tomography angiography OCTA

Myopic patients

Patients with myopia who meet the inclusion criteria

Diagnostic Test: Optical coherence tomography angiography OCTA

Interventions

Optical coherence tomography angiography OCTA DIAGNOSTIC_TEST

Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA

Also known as: OCTA

Healthy controls; Myopic patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \- 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• M. Tarek A Mosutafa, MD

  Lecturer of ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 22, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

EG (1)