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Optical Coherence Tomography Angiography in Myopic Patients

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT04135209
Collaborator
(none)
55
Enrollment
1
Location
17
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
55 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in angiography between the 2 groups [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Minia University Minya Minia Egypt 61111

    Sponsors and Collaborators

    • Minia University

    Investigators

    • Principal Investigator: M. Tarek A Mosutafa, MD, Lecturer of ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M. Tarek A. Moustafa, Lecturer of Ophthalmology, Minia University
    ClinicalTrials.gov Identifier:
    NCT04135209
    Other Study ID Numbers:
    • 68-7/2018
    First Posted:
    Oct 22, 2019
    Last Update Posted:
    Oct 22, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M. Tarek A. Moustafa, Lecturer of Ophthalmology, Minia University
    Optical coherence tomography
    Angiography
    Myopia
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Oct 22, 2019