Primary GlaucomaNCT04515030
Changes of Trace Elements in Aqueous Humor, Blood and Tears and Analysis of Related Factors
An observational study of Primary Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Glaucoma
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with primary glaucoma. Age-related cataract. Normal population.
Who may be able to join
- 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.
Show all 13Show fewer
- 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. -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Changes of Trace Elements in Aqueous Humor, Blood and Tears of Patients With Primary Glaucoma and Analysis of Related Factors
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.
Read the 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.
- Conditions
- Primary Glaucoma
- Keywords
- trace element, Age-related cataract, Aqueous humor, blood, tears., Flow-Injection-Inductively-Coupled-Plasma-Mass-Spectrometry, Metabonomics, Genomics
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Specimens were collected before and after surgery for approximately 1 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start20 Aug 2020
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary GlaucomaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiqing Li, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515030
- Sponsor's protocol ID
- 2020KYPJ120
- Status last verified
- Dec 2021
- First submitted
- 10 Aug 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 15158634Li 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.
PubMed 28049831Li Y, Liu Z, Li Z, Zhu Y, Liang S, Liu H, Xue J, Lin J, Deng Y, Deng C, Zeng S, Zhuo Y, Li Y. Levels of Zinc, Iron, and Copper in the Aqueous Humor of Patients with Primary Glaucoma. Biomolecules. 2025 Jul 4;15(7):962. doi: 10.3390/biom15070962.
PubMed 40723834
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Trace Elements in Aqueous Humor, Blood and Tears of Patients With Primary Glaucoma and Analysis of Related Factors
- ClinicalTrials.gov ID
- NCT04515030
- Acronym / sponsor ID
- 2020KYPJ120
- Conditions
- Primary Glaucoma
- Keywords
- trace element, Age-related cataract, Aqueous humor, blood, tears., Flow-Injection-Inductively-Coupled-Plasma-Mass-Spectrometry, Metabonomics, Genomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary glaucoma. Age-related cataract. Normal population.
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentrations of trace elements in aqueous humor, blood, and tears.
Time frame: Specimens were collected before and after surgery for approximately 1 years.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 15158634Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
- Background: PubMed 28049831Li 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.
- Derived from this study: PubMed 40723834Li Y, Liu Z, Li Z, Zhu Y, Liang S, Liu H, Xue J, Lin J, Deng Y, Deng C, Zeng S, Zhuo Y, Li Y. Levels of Zinc, Iron, and Copper in the Aqueous Humor of Patients with Primary Glaucoma. Biomolecules. 2025 Jul 4;15(7):962. doi: 10.3390/biom15070962.
- Primary Open-Angle GlaucomaLink provided by the sponsor.
- Mobile Zinc Increases Rapidly in the Retina After Optic Nerve Injury and Regulates Ganglion Cell Survival and Optic Nerve RegenerationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiqing Li principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentrations of trace elements in aqueous humor, blood, and tears. (time frame: Specimens were collected before and after surgery for approximately 1 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.