Optical Coherence Tomography Angiography in Myopic Patients

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135209
• Other study ID #: 68-7/2018
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Diagnostic Test:
• Optical coherence tomography angiography OCTA
Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA

Locations

Country	Name	City	State
Egypt	Minia University	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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