- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340061
The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
March 24, 2024 updated by: Henan Provincial People's Hospital
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Henan provincial people's hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Outpatients
Description
Inclusion Criteria:
- Clinical diagnosis of primary glaucoma.
- Must be able to cooperate to complete the inspection.
Exclusion Criteria:
- Secondary glaucoma.
- Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.
- trauma
- congenital eye malformations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
|
|
Treatment group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOP
Time Frame: through study completion, an average of 2 years.
|
Intraocular pressure
|
through study completion, an average of 2 years.
|
bIOP
Time Frame: through study completion, an average of 2 years.
|
Biomechanical intraocular pressure.
Corneal Biomechanics Parameters.
|
through study completion, an average of 2 years.
|
ACD
Time Frame: through study completion, an average of 2 years.
|
Anterior chamber depth.
Anterior Chamber Parameters.
|
through study completion, an average of 2 years.
|
ACW
Time Frame: through study completion, an average of 2 years.
|
Anterior chamber width.
Anterior Chamber Parameters.
|
through study completion, an average of 2 years.
|
SSI
Time Frame: through study completion, an average of 2 years.
|
Stress-strain index.
Corneal Biomechanics Parameters.
|
through study completion, an average of 2 years.
|
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
|
through study completion, an average of 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Qian Liu, Henan Provincial People's Hospital, Henan Eye Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 10, 2024
First Submitted That Met QC Criteria
March 24, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 24, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Qianyu Wu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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