GlaucomaNCT06340061
The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
An observational study of Glaucoma, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Read more about this study
- Who is it for?
- Ages 22 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Observational study
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to 31 Dec 2024
- 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 22 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients
Who may be able to join
- Clinical diagnosis of primary glaucoma.
- Must be able to cooperate to complete the inspection.
Who cannot join
- Secondary glaucoma.
- Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.
- trauma
- congenital eye malformations
Trial locations and contacts
1 site in 1 country.
About this study
The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma
- Conditions
- Glaucoma
- Being tested
- Observational study
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Not described Receives: Other: Observational study | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular pressure
Measured: through study completion, an average of 2 years.
bIOP
Biomechanical intraocular pressure. Corneal Biomechanics Parameters.
Measured: through study completion, an average of 2 years.
ACD
Anterior chamber depth. Anterior Chamber Parameters.
Measured: through study completion, an average of 2 years.
ACW
Anterior chamber width. Anterior Chamber Parameters.
Measured: through study completion, an average of 2 years.
SSI
Stress-strain index. Corneal Biomechanics Parameters.
Measured: through study completion, an average of 2 years.
VF
visual field. The severity of glaucoma is mainly based on the damage of the visual field
Measured: through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start20 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Liu, Principal investigator, Henan Provincial People's Hospital, Henan Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340061
- Sponsor's protocol ID
- Qianyu Wu
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
- ClinicalTrials.gov ID
- NCT06340061
- Acronym / sponsor ID
- Qianyu Wu
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2024 (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.
The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: Observational study |
| Control group | – | – |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary glaucoma.
- Must be able to cooperate to complete the inspection.
Key exclusion criteria (4 listed)
- Secondary glaucoma.
- Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.
- trauma
- congenital eye malformations
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 |
|---|---|---|
| Observational studyThe ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma | Other | Treatment group |
Primary outcome
IOP
Time frame: through study completion, an average of 2 years.
Intraocular pressure
bIOP
Time frame: through study completion, an average of 2 years.
Biomechanical intraocular pressure. Corneal Biomechanics Parameters.
ACD
Time frame: through study completion, an average of 2 years.
Anterior chamber depth. Anterior Chamber Parameters.
ACW
Time frame: through study completion, an average of 2 years.
Anterior chamber width. Anterior Chamber Parameters.
SSI
Time frame: through study completion, an average of 2 years.
Stress-strain index. Corneal Biomechanics Parameters.
VF
Time frame: through study completion, an average of 2 years.
visual field. The severity of glaucoma is mainly based on the damage of the visual field
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Qian Liu principal investigator
Henan Provincial People's Hospital, Henan Eye Hospital
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 Henan Provincial People's Hospital 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 4 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 1 Apr 2024. 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?
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?
IOP (time frame: through study completion, an average of 2 years.). The study lists 6 primary outcomes in all. 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 1 Apr 2024.