Clinical trial NCT05803174: Screening and Identification of Biomarkers for High Myopia by a Rapid Method
Official title: Screening and Identification of Biomarkers for High Myopia by a Rapid Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Myopia
Keywords: biomarkers
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Tsinghua University
First posted: 2023-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Children 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;

Adults Inclusion Criteria

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.

Primary outcomes:
measure: Concentration of TNF-α in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
Secondary outcomes:
measure: Concentration of IL-1 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
Other outcomes:
measure: Concentration of IL-10 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
measure: Concentration of IL-6 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
measure: Concentration of TIMP in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
measure: Concentration of MMP2 in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
measure: Concentration of EGF in tear fluid, saliva and blood sample among emmetropic, low and moderate myopic, and high myopic groups
timeFrame: June 30, 2023
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Shi-Ming Li
role: PRINCIPAL_INVESTIGATOR
References: