Study on the Measurement of Retinal Blood Flow in Children

Completed

• Conditions: Myopia

• Registration Number: NCT04689503
• Lead Sponsor: Wenzhou Medical University

Brief Summary

In order to provide reference for clinical application, the normal values of retinal blood flow parameters in Chinese healthy children were measured by oct-angiography. Meanwhile, the repeatability and consistency of retinal blood flow parameters measured by oct-angiography in children were further analyzed, and the correlation of retinal blood flow parameters with eye axis, choroidal thickness, age and diopter was analyzed, so as to provide basis for clinical diagnosis of children's ophthalmopathy. Objective to study the effect of short-term optical defocusing on retinal blood flow parameters, and analyze the correlation between the changes of posterior segment parameters before and after short-term optical defocusing, so as to provide the basis for the possible compensation mechanism of posterior segment optical defocusing, and further understand the possible physiological mechanism of myopia.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2017-05-25
• Study Completion: 2019-11-11
• Status Verified: 2019-12
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. The subjects should be 6-18 years old, with parents' consent and be able to abide by the experimental rules;
2. uncorrected visual acuity or spectacle corrected visual acuity ≥ 1.0, and each eye can fix the target;
3. equivalent spherical lens range + 0.50D ~ - 6.00D, binocular spherical lens anisometropia ≤ 1D, anisometropia ≤ 1.5D;
4. frame glasses can be worn for patients with ametropia, and hard contact lenses can not be worn for at least 4 weeks, and anisometropia can not be worn for 2 weeks
5. intraocular pressure in the normal range (9mmhg-21mmhg)

Exclusion Criteria

1. Patients with history of ocular trauma and surgery;
2. patients with ocular organic lesions or systemic diseases;
3. patients with dry eye;
4. patients in the treatment period using drugs (such as atropine eye drops);
5. patients with poor cooperation or unqualified image quality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood flow density measurement	2017.05.01-2019.11.11	The vascular density was defined as the percentage of the area occupied by the vascular cavity after secondary reconstruction. The percentage of vascular lumen in macular area is automatically displayed based on the early treatment of diabetic retinopathy study (ETDRS) partition (i.e. macular area, paramacular area, temporal area, last time area, nasal area and inferior area), and the other partition method is based on the "Nine Palace" partition (i.e. central macular area, supratemporal area, superior area, Supranasal area, nasal area, infranasal area, inferior area, infratemporal area and temporal area)

Secondary Outcome Measures

Name	Time	Method
Macular avascular area measurement	2017.05.01-2019.11.11	The new non vascular area measurement option was used to automatically measure the FAZ area. The boundary of avascular zone is detected and defined by system software and quantified automatically. The reference range of shallow retinal foveal avascular zone,It was defined as within 60 LM from the inner limiting membrane. In the images of shallow and deep capillary layers, the foveal avascular zone is measured automatically by clicking the center of foveal avascular zone.

Trial Locations

Locations (1)

The affiliated Eye Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China