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Completed

NCT Number: NCT04631991

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aslı Çentinkaya Yaprak

Antalya, 070059, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive ophthalmologic examination

Diagnostic Test

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.

Primary outcomes

  1. Optic nerve head vessel density

    Time frame: 10 minutes

    Optic nerve head vessel density assessed with optical coherence tomography angiography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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