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

NCT ID: NCT04515030

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2022-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 PatternĀ® 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 PatternĀ® Guidelines. Ophthalmology 2016;123:P41-111. doi:10.1016/j.ophtha.2015.10.053

No interventions assigned to this group

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 PatternĀ®. Ophthalmology 2017;124:P1-119. doi:10.1016/j.ophtha.2016.09.027

No interventions assigned to this group

Normal control

Normal people without ocular diseases were enrolled as normal control.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 \< 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yiqing Li

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 15158634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28049831 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/28049831/

Mobile Zinc Increases Rapidly in the Retina After Optic Nerve Injury and Regulates Ganglion Cell Survival and Optic Nerve Regeneration

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020KYPJ120

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Asia Glaucoma Registry
NCT05278299 UNKNOWN
Retinal Blood Flow and Autoregulation
NCT05344274 RECRUITING PHASE4