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

• Sponsor: Akdeniz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04631991
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 76.1

Study Details

Study Description

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	Phase
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

• 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: Nov 10, 2020
• Actual Primary Completion Date: Dec 5, 2020
• Actual Study Completion Date: Dec 8, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Optic nerve head vessel density [10 minutes]

   Optic nerve head vessel density assessed with optical coherence tomography angiography

Secondary Outcome Measures

1. Choriocapillaris flow area [10 minutes]

   Choriocapillaris flow area assessed with optical coherence tomography angiography

2. Subfoveal choroidal thickness [10 minutes]

   Subfoveal choroidal thickness assessed with optical coherence tomography angiography

3. Foveal avascular zone [10 minutes]

   Foveal avascular zone assessed with optical coherence tomography angiography

4. Subfoveal central macular thickness [10 minutes]

   Subfoveal central macular thickness assessed with optical coherence tomography angiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Aslı Çentinkaya Yaprak	Antalya		Turkey	070059

Sponsors and Collaborators

• Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aslı Çetinkaya Yaprak, Principal Investigator, Akdeniz University
• ClinicalTrials.gov Identifier: NCT04631991
• Other Study ID Numbers: 18062020-167
• First Posted: Nov 17, 2020
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jan 14, 2021