Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optical Coherence Tomography Angiography in Myopic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135209
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
M. Tarek A. Moustafa, Minia University

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
Myopia 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: 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 Name: OCTA




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135209


Locations
Layout table for location information
Egypt
Minia University
Minya, Minia, Egypt, 61111
Sponsors and Collaborators
Minia University
Investigators
Layout table for investigator information
Principal Investigator: M. Tarek A Mosutafa, MD Lecturer of ophthalmology
Layout table for additonal information
Responsible Party: M. Tarek A. Moustafa, Lecturer of Ophthalmology, Minia University
ClinicalTrials.gov Identifier: NCT04135209    
Other Study ID Numbers: 68-7/2018
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

Layout table for additional information
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, Minia University:
Optical coherence tomography
Angiography
Myopia
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases