Optical Coherence Tomography Angiograph… | Clinical Trial

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Minia University

Minya, Minya Governorate, 61111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical coherence tomography angiography OCTA

Diagnostic Test

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

Other names: OCTA

Primary outcomes

Difference in angiography between the 2 groups

Time frame: through study completion, an average of 4 weeks

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)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 22, 2019
Registry last updated: Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed