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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631991
• Other study ID #: 18062020-167
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: December 8, 2020

Study information

• Verified date: January 2021
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 8, 2020
• Est. primary completion date: December 5, 2020
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Asli Çentinkaya Yaprak	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve head vessel density	Optic nerve head vessel density assessed with optical coherence tomography angiography	10 minutes
Secondary	Choriocapillaris flow area	Choriocapillaris flow area assessed with optical coherence tomography angiography	10 minutes
Secondary	Subfoveal choroidal thickness	Subfoveal choroidal thickness assessed with optical coherence tomography angiography	10 minutes
Secondary	Foveal avascular zone	Foveal avascular zone assessed with optical coherence tomography angiography	10 minutes
Secondary	Subfoveal central macular thickness	Subfoveal central macular thickness assessed with optical coherence tomography angiography	10 minutes