Clinical Trials Directory

Trials / Completed

CompletedNCT04631991

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Akdeniz University · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTComprehensive ophthalmologic examinationMeasurements 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.

Timeline

Start date
2020-11-10
Primary completion
2020-12-05
Completion
2020-12-08
First posted
2020-11-17
Last updated
2021-01-14

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04631991. Inclusion in this directory is not an endorsement.