- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515030
Changes of Trace Elements in Aqueous Humor, Blood and Tears and Analysis of Related Factors
Changes of Trace Elements in Aqueous Humor, Blood and Tears of Patients With Primary Glaucoma and Analysis of Related Factors
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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. -
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The concentrations of trace elements in aqueous humor, blood, and tears.
Time Frame: Specimens were collected before and after surgery for approximately 1 years.
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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.
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Specimens were collected before and after surgery for approximately 1 years.
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Collaborators and Investigators
Investigators
- Principal Investigator: Yiqing Li, Zhongshan Ophthalmic Center, Sun Yat-sen University, China
Publications and helpful links
General Publications
- Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020KYPJ120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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