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

NCT ID: NCT05803174

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2023-07-31

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.

Detailed Description

Myopia has emerged as a serious public health issue, with the prevalence increasing rapidly worldwide, especially in East Asia. Increasingly early onset of myopia leads to high myopia with sight-threatening complications (e.g., secondary cataracts, glaucoma, and retinal detachment) that cannot be treated by optical means.

A key goal of myopia research over the past decades has been to identify those sensitive biomarkers. Accurate monitoring of myopic-specific biomarkers is desirable for achieving early diagnosis, progression assessment, and prognostic management.

However, measurement of levels of MMPs in human have been restricted to aqueous humors, which is invasive and the findings are difficult to be replicated in other studies. In order to achieve the goal of convenient high myopic detection, the use of a panel of biomarkers using a multiplex approach may indeed be rapid and highly reproducible with potentially higher sensitivity and specificity than single biomarkers, such as MMP 2 for the early detection of high myopia.

In this study we have used a newly developed immunoassay technology, and identified a panel of novel biomarkers for early detection of high myopia by non-invasively evaluating several biomarkers that are measurable in the saliva and tear fluid of adults.

Conditions

High Myopia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Emmetropic subjects

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

blood sample

Intervention Type: 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.

Low and moderate myopic subjects

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

blood sample

Intervention Type: 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.

High myopic subjects

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

blood sample

Intervention Type: 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.

Interventions

blood sample

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

saliva, tear fluid

Eligibility Criteria

Inclusion Criteria

1. Children aged 6-17

2. 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;

3. Best corrected visual acuity of either eye were all ≥ 1.0;

4. The range of myopia in either eye was -15 D ≤ SE ≤ +1.0 D;

5. Astigmatism of either eye less than -5.0 D;

6. Anisometropia ≤ -1.5 D;

7. There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.

8. Intraocular pressure of either eye is of 10 to 21 mmHg;

9. On the basis of full understanding, children and their guardians sign the informed consent;

1. adults aged 18-35

2. 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;

3. Best corrected visual acuity of either eye were all ≥ 1.0;

4. The range of myopia in either eye was -15 D ≤ SE ≤ +1.0 D;

5. Astigmatism of either eye less than -5.0 D;

6. Anisometropia ≤ -1.5 D;

7. There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.

8. Intraocular pressure of either eye is of 10 to 21 mmHg;

9. On the basis of full understanding, adults sign the informed consent;

Exclusion Criteria

1. Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for adults and children over 6 years old;

2. Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;

3. Secondary myopia, genetic disease or connective tissue- related myopia;

4. Moderate or severe ptosis;

5. Congenital cataract, glaucoma;

6. Other fundus diseases other than myopic related fundus lesions;

7. Intraocular or refractive surgery history;

8. 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tsinghua University

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shi-Ming Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

010133

Identifier Type: -

Identifier Source: org_study_id