Primary Angle Closure GlaucomaNCT06184620
Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
An observational study of Primary Angle Closure Glaucoma, run by Guangfu Dang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 47 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Angle Closure Glaucoma
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Mar 2023
- 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 47 to 91 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Primary Angle Closure Glaucoma
- Keywords
- primary angle closure glaucoma, UBM, lens zonule
- Medical subject headings
- Glaucoma, Angle-Closure
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 |
|---|---|---|
| PACG group | All patients in the experimental group met the diagnostic criteria of primary angle-closure glaucoma in the Chinese Glaucoma Guidelines(2020). | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
Measured: before operation
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
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
Measured: before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Dec 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Angle Closure 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangfu Dang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guangfu Dang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184620
- Sponsor's protocol ID
- YXLL-KY-2023(047)
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
- ClinicalTrials.gov ID
- NCT06184620
- Acronym / sponsor ID
- YXLL-KY-2023(047)
- Conditions
- Primary Angle Closure Glaucoma
- Keywords
- primary angle closure glaucoma, UBM, lens zonule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Guangfu DangUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 28 Dec 2023 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACG group | – | –All patients in the experimental group met the diagnostic criteria of primary angle-closure glaucoma in the Chinese Glaucoma Guidelines(2020). |
| 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 |
Who may qualify
- Ages
- 47 to 91 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
Time frame: before operation
Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),
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
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
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 28 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Angle Closure Glaucoma, run by Guangfu Dang 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 3 inclusion and 5 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 28 Dec 2023. 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?
Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD), (time frame: before operation). The study lists 2 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 28 Dec 2023.