Study on the Measurement of Retinal Blood Flow in Children

Study on the Measurement of Retinal Blood Flow in Children Based on Oct Angiography and the Effect of Optical Defocus Application

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.

Study Overview

• Status: Completed
• Conditions: Myopia

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • The Affiliated Eye Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children volunteers with normal corrected visual acuity

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow density measurement	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)	2017.05.01-2019.11.11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular avascular area measurement	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.	2017.05.01-2019.11.11

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 25, 2017
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: retinal blood flow in children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No