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Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA

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ClinicalTrials.gov Identifier: NCT04631991
Recruitment Status : Completed
First Posted : November 17, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Aslı Çetinkaya Yaprak, Akdeniz University

Study Description
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Brief Summary:
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.

Condition or disease Intervention/treatment
Myopia Diagnostic Test: Comprehensive ophthalmologic examination

Detailed Description:

Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination, including measurements of best-corrected visual acuity, refractive error; intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination and OCTA imaging are included. The best-corrected visual acuity is convert into the logarithm of minimal angle resolution. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.

Right eye of each participant is included in the study. If the right eye shows any exclusion criteria, then the left eye is selected for enrollment. Eyes with an AL longer than 26 mm are included in the HM group. The classification of myopic maculopathy is applied in identification of fundus alterations. Patients with category 0 (no myopic retinopathy lesions) and category 1 (tessellated fundus) are included in the study.

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography
Actual Study Start Date : November 10, 2020
Actual Primary Completion Date : December 5, 2020
Actual Study Completion Date : December 8, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-pathological high myopia
Comprehensive ophthalmologic examination
 Diagnostic Test: Comprehensive ophthalmologic examination
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
Control
Comprehensive ophthalmologic examination
 Diagnostic Test: Comprehensive ophthalmologic examination
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.


Outcome Measures
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Primary Outcome Measures :
  1. Optic nerve head vessel density [ Time Frame: 10 minutes ]
    Optic nerve head vessel density assessed with optical coherence tomography angiography


Secondary Outcome Measures :
  1. Choriocapillaris flow area [ Time Frame: 10 minutes ]
    Choriocapillaris flow area assessed with optical coherence tomography angiography

  2. Subfoveal choroidal thickness [ Time Frame: 10 minutes ]
    Subfoveal choroidal thickness assessed with optical coherence tomography angiography

  3. Foveal avascular zone [ Time Frame: 10 minutes ]
    Foveal avascular zone assessed with optical coherence tomography angiography

  4. Subfoveal central macular thickness [ Time Frame: 10 minutes ]
    Subfoveal central macular thickness assessed with optical coherence tomography angiography


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Study population includes a convenience sampling from the patients admitted to outpatient clinic between November 2020 and December 2020.
Criteria

Inclusion Criteria:

  • Patients with category 0 (no myopic retinopathy lesions)
  • Patients with category 1 (tessellated fundus)

Exclusion Criteria:

  • poor image quality (signal strength index (SSI) <60) due to unstable fixation
  • IOP >21 mm Hg; logMAR > 0.1
  • pre-existing ophthalmic pathologies
  • prior ocular surgery
  • systemic chronic disease which can cause retinopathy
  • such as diabetes mellitus, hypertension etc.
Contacts and Locations
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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): NCT04631991


Locations
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Turkey
Aslı Çentinkaya Yaprak
Antalya, Turkey, 070059
Sponsors and Collaborators
Akdeniz University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aslı Çetinkaya Yaprak, Principal Investigator, Akdeniz University
ClinicalTrials.gov Identifier: NCT04631991    
Other Study ID Numbers: 18062020-167
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases