Study on the Measurement of Retinal Blood Flow in Children

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689503
• Other study ID #: retinal blood flow in children
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: November 11, 2019

Study information

• Verified date: December 2019
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 11, 2019
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Locations

Country	Name	City	State
China	The affiliated Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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