Optical Coherence Tomography Angiography in Myopic Patients

NCT ID: NCT04135209

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Myopia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

Healthy individuals of age-matched

Optical coherence tomography angiography OCTA

Intervention Type DIAGNOSTIC_TEST

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

Myopic patients

Patients with myopia who meet the inclusion criteria

Optical coherence tomography angiography OCTA

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Optical coherence tomography angiography OCTA

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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OCTA

Eligibility Criteria

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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.


* \- 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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M. Tarek A. Moustafa

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M. Tarek A Mosutafa, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of ophthalmology

Locations

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Minia University

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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68-7/2018

Identifier Type: -

Identifier Source: org_study_id

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