GlaucomaNCT04943107
Effect of Antihypertensive Drugs on Glaucoma Patients
An observational study of Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient from ophthalmology and cardiology clinic
Who may be able to join
- age no less than 18 years
- best corrected visual acuity better than decimal 0.3
Who cannot join
- secondary glaucoma
- secondary hypertension
- glaucoma-related operation history
- pregnancy or lactation period
- uncooperative with retinal examination
- severe opacity with refracting media in eye
Show all 9Show fewer
- severe retinal diseases and neuropathy
- congenital retinal optic nerve abnormality
- other systemic diseases that influence hypertension and glaucoma assessment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Kaijun Wand, MD, +86 1360052917, wkj992@126.com
About this study
It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. In order to explore whether antihypertensive medications would influence the neuropathy among glaucomatous population, we designed a cross-sectional observational study to analyze the retinal status among glaucoma patients with use of antihypertensive medication.
Read the detailed description
we designed a cross-sectional obeservational study to analyze the retinal status among glaucoma patients with use of hyertensive medication.
- Conditions
- Glaucoma
- Being tested
- no intervention
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, only measurement of blood pressure, intraocular pressure, hypertensive history questionnaire, retinal imaging, optical coherence tomography examination etc..
| Study group | Role | What they receive |
|---|---|---|
| healthy control | adults without glaucoma history or hypertension history Receives: Other: no intervention | |
| glaucoma patients | adults with primary glaucoma history; without glaucoma-related operation history; without hypertension history Receives: Other: no intervention | |
| hypertension patients | adults with primary hypertension history; without glaucoma history Receives: Other: no intervention | |
| glaucoma+hypertension | adults with primary glaucoma history and primary hypertension history; without glaucoma-related operation history Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal nerve fiber layer thickness
retinal nerve fiber layer thickness measured by optical coherence tomography
Measured: within 3 months from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 May 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaijun Wang, MD, Principal investigator, Second Affiliated Hospital of College of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943107
- Sponsor's protocol ID
- 2021-0287
- Status last verified
- May 2021
- First submitted
- 16 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antihypertensive Drugs on Glaucoma Patients
- ClinicalTrials.gov ID
- NCT04943107
- Acronym / sponsor ID
- 2021-0287
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jun 2021 (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.
It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. In order to explore whether antihypertensive medications would influence the neuropathy among glaucomatous population, we designed a cross-sectional observational study to analyze the retinal status among glaucoma patients with use of antihypertensive medication.
Detailed description
we designed a cross-sectional obeservational study to analyze the retinal status among glaucoma patients with use of hyertensive medication.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | Other: no interventionadults without glaucoma history or hypertension history |
| glaucoma patients | – | Other: no interventionadults with primary glaucoma history; without glaucoma-related operation history; without hypertension history |
| hypertension patients | – | Other: no interventionadults with primary hypertension history; without glaucoma history |
| glaucoma+hypertension | – | Other: no interventionadults with primary glaucoma history and primary hypertension history; without glaucoma-related operation history |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient from ophthalmology and cardiology clinic
Key inclusion criteria (2 listed)
- age no less than 18 years
Key exclusion criteria (9 listed)
- secondary glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention, only measurement of blood pressure, intraocular pressure, hypertensive history questionnaire, retinal imaging, optical coherence tomography examination etc.. | Other | glaucoma patients, glaucoma+hypertension, healthy control, hypertension patients |
Primary outcome
retinal nerve fiber layer thickness
Time frame: within 3 months from recruitment
retinal nerve fiber layer thickness measured by optical coherence tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
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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.
Kaijun Wang, MD principal investigator
Second Affiliated Hospital of College of Medicine, Zhejiang University
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 Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaijun Wang, MD (+86 13600529217, wkj992@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal nerve fiber layer thickness (time frame: within 3 months from recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2021.