Screening and Identification of Biomarkers for High Myopia by a Rapid Method

NCT05803174 | Unknown

• 1 other identifier: 010133
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To screen and identify sensitive biomarkers for high myopia via a robust, convenient, and cost-effective approach according to the association between high myopia and concentration of biomarkers in tear fluid, saliva and blood among adults and children.

Conditions

High Myopia

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

• Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups

  TNF-α: Tumor necrosis factor is an adipokine and a cytokine.

  June 30, 2023

Secondary Outcomes (1)

• Concentration of IL-1 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups

  June 30, 2023

Other Outcomes (5)

• Concentration of IL-10 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups

  June 30, 2023

• Concentration of IL-6 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups

  June 30, 2023

• Concentration of TIMP in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups

  June 30, 2023

Study Arms (3)

Emmetropic subjects

Spherical equivalent (Diopter, D) to be between -0.5 and +0.5 D

Diagnostic Test: blood sample

Low and moderate myopic subjects

Spherical equivalent (Diopter, D) to be less than -0.5 but over -6.0D

Diagnostic Test: blood sample

High myopic subjects

Spherical equivalent (Diopter, D) to be over or equal to -6.0D

Diagnostic Test: blood sample

Interventions

blood sample DIAGNOSTIC_TEST

Blood collection Circulating serum concentrations of melatonin and dopamine were determined from fasting blood samples. Participants were required to fast from 10 pm the previous evening. A 5 mL serum blood sample was collected from the antecubital vein between 8.30 am and 10 am. Tear collection Tear samples were collected using Schirmer's strip without anesthesia between 8:30-10:00am. Tears were extracted in 200 μl of 1 X Phosphate Buffered Saline with 0.1% Tween-20 (PBST). Saliva collection Saliva samples were collected via the "passive drool" method with subjects in a seated position. Subjects were asked to rinse their mouth with water 10 minutes prior to saliva collection and to refrain from using lip makeup during the sampling period.

Also known as: saliva, tear fluid

Emmetropic subjects; High myopic subjects; Low and moderate myopic subjects

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

There are two levels of research, namely children and adults. Each level is divided into three groups of 20 subjects each. So about 120 subjects are anticipated in total. Taken into account the proportion of exclusion, 150 subjects are invited to recruitment.

You may qualify if:

• Children aged 6-17
• Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
• Best corrected visual acuity of either eye were all ≥ 1.0;
• The range of myopia in either eye was -15 D ≤ SE ≤ +1.0 D;
• Astigmatism of either eye less than -5.0 D;
• Anisometropia ≤ -1.5 D;
• There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
• Intraocular pressure of either eye is of 10 to 21 mmHg;
• On the basis of full understanding, children and their guardians sign the informed consent;
• adults aged 18-35
• Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
• Best corrected visual acuity of either eye were all ≥ 1.0;
• The range of myopia in either eye was -15 D ≤ SE ≤ +1.0 D;
• Astigmatism of either eye less than -5.0 D;
• Anisometropia ≤ -1.5 D;

You may not qualify if:

• Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for adults and children over 6 years old;
• Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
• Secondary myopia, genetic disease or connective tissue- related myopia;
• Moderate or severe ptosis;
• Congenital cataract, glaucoma;
• Other fundus diseases other than myopic related fundus lesions;
• Intraocular or refractive surgery history;
• The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;
• (10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Tsinghua University: collaborator

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100073, China

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shi-Ming Li

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: March 20, 2023
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)