Changes of Trace Elements in Aqueous Humor, Blood and Tears and Analysis of Related Factors

NCT04515030 | Completed DMC

• 1 other identifier: 2020KYPJ120
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Glaucoma

Keywords

trace element; Age-related cataract; Aqueous humor, blood, tears.; Flow-Injection-Inductively-Coupled-Plasma-Mass-Spectrometry; Metabonomics; Genomics

Outcome Measures

Primary Outcomes (1)

• The concentrations of trace elements in aqueous humor, blood, and tears.

  The aqueous humor, blood, and tears samples were collected from patients with primary glaucoma, senile cataract, and normal people. The concentrations of trace elements were measured by inductively coupled plasma mass spectrometry (FI-ICP-MS), metabonomics and genomics.

  Specimens were collected before and after surgery for approximately 1 years.

Study Arms (3)

Primary glaucoma

Primary glaucoma patients were diagnosed based on guidelines \[1-2\]. Patients with a confirmed diagnosis of primary glaucoma were enrolled and classified into the acute angle-closure crisis (AACC), primary angle-closure glaucoma (PACG), and primary open-angle glaucoma (POAG) subgroups. 1. Prum BE, Herndon LW, Moroi SE, et al. Primary Angle Closure Preferred Practice Pattern® Guidelines. Ophthalmology 2016;123:P1-40. doi:10.1016/j.ophtha.2015.10.049 2. Prum BE, Rosenberg LF, Gedde SJ, et al. Primary Open-Angle Glaucoma Preferred Practice Pattern® Guidelines. Ophthalmology 2016;123:P41-111. doi:10.1016/j.ophtha.2015.10.053

Senile cataract

Senile cataract patients were diagnosed based on guideline \[3\]. Patients with a confirmed diagnosis of senile cataract were enrolled and considered as controls for aqueous humor-related analysis. \[3\] Olson RJ, Braga-Mele R, Chen SH, et al. Cataract in the Adult Eye Preferred Practice Pattern®. Ophthalmology 2017;124:P1-119. doi:10.1016/j.ophtha.2016.09.027

Normal control

Normal people without ocular diseases were enrolled as normal control.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary glaucoma. Age-related cataract. Normal population.

You may qualify if:

• \- If you meet the following conditions, you can participate in our study and become a subject in the case group:
• those who are over 50 years old and can complete all the examinations and examinations.
• other secondary and developmental factors have been excluded and diagnosed as primary glaucoma.
• 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:
• those who are over 18 years old and can complete all the tests and examinations.
• other factors have been excluded and age-related cataract has been clearly diagnosed.
• 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:
• those who are over 50 years old and can complete all the tests and examinations.
• No previous history of ophthalmopathy (except ametropia, strabismus and age-related cataract).
• normal eye examination (intraocular pressure \< 21mmHg, chamber angle open, cup / plate ratio normal, visual field normal).
• can cooperate with those who take part in blood test and collect enough tears. -

You may not qualify if:

• those who have a history of eye trauma, eye surgery or eye laser.
• 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.).
• 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.).
• pregnant, lactating and pregnant women.
• those who refuse to sign the informed consent form due to discomfort or other reasons or voluntarily withdraw from the researcher.
• those who are unable to cooperate with the relevant inspection and inspection

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.

  PMID: 15158634 BACKGROUND

• 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.

  PMID: 28049831 BACKGROUND

Related Links

• Primary Open-Angle Glaucoma
• Mobile Zinc Increases Rapidly in the Retina After Optic Nerve Injury and Regulates Ganglion Cell Survival and Optic Nerve Regeneration

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor, blood, tears.

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Yiqing Li

  Zhongshan Ophthalmic Center, Sun Yat-sen University, China

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 17, 2020
• Study Start: August 20, 2020
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: December 7, 2022

Record last verified: 2021-12

Locations

CN (1)