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

NCT ID: NCT04631991

Last Updated: 2021-01-14

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-10

Study Completion Date

2020-12-08

Brief Summary

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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.

Detailed Description

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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.

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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Non-pathological high myopia

Comprehensive ophthalmologic examination

Comprehensive ophthalmologic examination

Intervention Type 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.

Control

Comprehensive ophthalmologic examination

Comprehensive ophthalmologic examination

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Aslı Çetinkaya Yaprak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aslı Çentinkaya Yaprak

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yaprak AC, Yaprak L. Retinal microvasculature and optic disc alterations in non-pathological high myopia with optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3221-3227. doi: 10.1007/s00417-021-05216-x. Epub 2021 May 7.

Reference Type DERIVED
PMID: 33961111 (View on PubMed)

Other Identifiers

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18062020-167

Identifier Type: -

Identifier Source: org_study_id

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