Study on the Measurement of Retinal Blood Flow in Children

NCT04689503 | Completed DMC

• 1 other identifier: retinal blood flow in children
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Macular avascular area measurement

  2017.05.01-2019.11.11

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children volunteers with normal corrected visual acuity

You may qualify if:

• The subjects should be 6-18 years old, with parents' consent and be able to abide by the experimental rules;
• uncorrected visual acuity or spectacle corrected visual acuity ≥ 1.0, and each eye can fix the target;
• equivalent spherical lens range + 0.50D \~ - 6.00D, binocular spherical lens anisometropia ≤ 1D, anisometropia ≤ 1.5D;
• 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
• intraocular pressure in the normal range (9mmhg-21mmhg)

You may not qualify if:

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

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

The affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 30, 2020
• Study Start: May 1, 2017
• Primary Completion: May 25, 2017
• Study Completion: November 11, 2019
• Last Updated: December 30, 2020

Record last verified: 2019-12

Locations

CN (1)