- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06184620
Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
December 14, 2023 updated by: Guangfu Dang
The goal of this observational study is to discuss the correlation between primary angle-closure glaucoma and the state of the suspended ligament of the lens and the pathogenesis of PACG by measuring the biological data of primary angle-closure glaucoma and observing its anatomical changes.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients clinically diagnosed with Primary angle-closure glaucoma (PACG) and normal control patients from December 2020 to January 2022 were enrolled in this study.
Study Type
Observational
Enrollment (Actual)
263
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
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Shandong
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Jinan, Shandong, China, 250000
- guangfu Dang
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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
Non-Probability Sample
Study Population
From December 2020 to January 2022, patients with primary angle-closure glaucoma and normal control patients were diagnosed for the first time and intended to undergo cataract surgery in the ophthalmology department of the First Affiliated Hospital of Shandong First Medical University (Shandong Qiandfo Hospital).
Description
Inclusion Criteria:
- The depth of the anterior chamber is normal, and the whole corner of the chamber is open;
- The cup-to-plate ratio is less than 0.5;
- No family history of glaucoma.
Exclusion Criteria:
- Previous history of trauma or internal eye surgery in both eyes or one eye;
- Used "pilocarpine", "atropine" and other drugs to change the size of the pupil and the shape of the chamber Angle within 1 week;
- Combined with other eye diseases affecting the Angle and suspension ligament, such as uveitis, ciliary cyst, high myopia, retinal diseases, etc.;
- Can not cooperate with UBM and Angle scopy;
- Refuse to participate in this researcher.
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 |
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PACG group
All patients in the experimental group met the diagnostic criteria of primary angle-closure glaucoma in the Chinese Glaucoma Guidelines(2020).
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control group
The depth of the anterior chamber is normal, and the whole corner of the chamber is open; The cup-to-plate ratio is less than 0.5; No family history of glaucoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
Time Frame: before operation
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Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
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before operation
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Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions
Time Frame: before operation
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Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions
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before operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2020
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
December 14, 2023
First Posted (Actual)
December 28, 2023
Study Record Updates
Last Update Posted (Actual)
December 28, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YXLL-KY-2023(047)
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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