Clinical trial NCT04515030: Changes of Trace Elements in Aqueous Humor, Blood and Tears and Analysis of Related Factors
Official title: Changes of Trace Elements in Aqueous Humor, Blood and Tears of Patients With Primary Glaucoma and Analysis of Related Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Glaucoma
Keywords: trace element
Age-related cataract
Aqueous humor, blood, tears.
Flow-Injection-Inductively-Coupled-Plasma-Mass-Spectrometry
Metabonomics
Genomics
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary glaucoma. Age-related cataract. Normal population.

Brief summary: Trace elements are one of the indispensable substances in human body and play an important physiological role. Zinc is a trace element second only to iron in organisms, which is widely distributed in various systems and organs and plays an important biological role, and interacts with other trace elements such as copper and iron. With the improvement of detection methods, it is possible to detect the concentration of zinc and other trace elements in liquid samples. It is reported in the existing literature that there are significant changes in the concentration of trace elements in a variety of eye diseases. Our group intends to collect three kinds of samples (aqueous humor, blood and tears) of patients with primary glaucoma and age-related cataract who were treated in Sun Yat-sen Eye Center of Sun Yat-sen University from March 2020 to March 2021. Normal people with matched age and sex were recruited as normal control group (normal control group only collected blood and tear samples). Three methods (FI-ICP-MS, metabonomics and genomics) were used to study the concentration changes of patients with primary glaucoma in three kinds of body fluid samples, and the related factors were analyzed combined with clinical data, so as to provide a theoretical basis for studying the pathogenic mechanism and new prevention pathway of primary glaucoma.

Detailed description: Glaucoma is a group of optic nerve diseases characterized by progressive and irreversible degeneration of retinal ganglion cells and their axons. There are different opinions on the pathogenesis of glaucoma, which further reflects that the mechanism of glaucoma optic nerve injury is still in the exploratory stage, and there is still a long way to go to develop effective drugs to prevent or reverse the visual function damage in patients with glaucoma. Therefore, on the basis of previous studies, our research group explored and expanded whether there were similar pathological changes in patients with clinical glaucoma not only in aqueous humor, but also in blood and tear samples, and further studied the mechanism. Three kinds of samples (aqueous humor, blood and tears) were collected from patients with primary glaucoma and age-related cataract treated in Sun Yat-sen Eye Center of Sun Yat-sen University. Normal people with matched age and sex were recruited as normal control group (normal control group only collected blood and tear samples). Three methods of inductively coupled plasma mass spectrometry (FI-ICP-MS), metabonomics and genomics were used to study the concentration changes of patients with primary glaucoma in three kinds of body fluid samples, and the related factors were analyzed combined with clinical data, so as to provide a new theoretical basis for studying the pathogenic mechanism and new prevention pathway of primary glaucoma.

Eligibility criteria: Inclusion Criteria:

- If you meet the following conditions, you can participate in our study and become a subject in the case group:

1. those who are over 50 years old and can complete all the examinations and examinations.
2. other secondary and developmental factors have been excluded and diagnosed as primary glaucoma.
3. before anti-glaucoma surgery, you can take part in blood sampling examination and collect sufficient tears, and sufficient aqueous humor can be collected during the operation.

If you meet the following conditions, you can participate in our study and become a subject in the disease control group:

1. those who are over 18 years old and can complete all the tests and examinations.
2. other factors have been excluded and age-related cataract has been clearly diagnosed.
3. before cataract surgery, you can take part in blood sampling examination and collect sufficient tears, and sufficient aqueous humor can be collected during the operation.

If you meet the following conditions, you can participate in our study and become a normal control group:

1. those who are over 50 years old and can complete all the tests and examinations.
2. No previous history of ophthalmopathy (except ametropia, strabismus and age-related cataract).
3. normal eye examination (intraocular pressure \&lt; 21mmHg, chamber angle open, cup / plate ratio normal, visual field normal).
4. can cooperate with those who take part in blood test and collect enough tears. -

Exclusion criteria:

1. those who have a history of eye trauma, eye surgery or eye laser.
2. elevated intraocular pressure and glaucoma optic nerve damage caused by secondary or developmental factors (such as neovascularization, uveitis, trauma, lens-related factors, surgery, drugs, etc.).
3. suffering from other eye diseases that may affect metabolism (such as uveitis, ocular neovascularization, age-related macular degeneration, etc.) and major systemic diseases (such as heart disease, hypertension, hyperlipidemia, diabetes, hepatitis, digestive tract malabsorption, hypothyroidism, vitamin deficiency, mental illness, severe psoriasis, malignant tumors, etc.).
4. pregnant, lactating and pregnant women.
5. those who refuse to sign the informed consent form due to discomfort or other reasons or voluntarily withdraw from the researcher.
6. those who are unable to cooperate with the relevant inspection and inspection

Primary outcomes:
measure: The concentrations of trace elements in aqueous humor, blood, and tears.
timeFrame: Specimens were collected before and after surgery for approximately 1 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University, China
name: Yiqing Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
citation: Li Y, Andereggen L, Yuki K, Omura K, Yin Y, Gilbert HY, Erdogan B, Asdourian MS, Shrock C, de Lima S, Apfel UP, Zhuo Y, Hershfinkel M, Lippard SJ, Rosenberg PA, Benowitz L. Mobile zinc increases rapidly in the retina after optic nerve injury and regulates ganglion cell survival and optic nerve regeneration. Proc Natl Acad Sci U S A. 2017 Jan 10;114(2):E209-E218. doi: 10.1073/pnas.1616811114. Epub 2017 Jan 3.