Glaucoma, Angle-ClosureNCT06143943
Anterior Segment Anatomic Parameters for Risk Profiling of Primary Angle-closure Glaucoma
An observational study of Glaucoma, Angle-Closure, run by Min Ke at 1 site in China.
Trial summary
The goal of this observational study is to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG). Read more about this study
- Who is it for?
- Ages 30 to 92 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 28 Feb 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 30 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PACG and anterior chamber angle stenosis were enrolled in this study and excluded from other diseases affecting the structure of the anterior segment of the eye, as well as a history of intraocular surgery.
Who may be able to join
- Primary angle-closure glaucoma （PACG) was defined as an occlusion angle with peripheral anterior synechiae and intraocular pressure (IOP) > 21 mmHg or associated with glaucomatous optic neuropathy. The following conditions were identified as possible glaucomatous optic neuropathies, including a vertical cup-to-disc ratio ≥ 0.6, vertical cup-to-disc ratio asymmetry ≥ 0.2, optic disc haemorrhage, and visible retinal nerve fibre layer defect.
- Participants with narrow angle (NA) were selected from among patients with cataracts. NA was defined as a trabecular-iris angle (TIA) < 15° on anterior segment optical coherence tomography, with the exclusion of glaucomatous optic neuropathy or visual field loss.
Who cannot join
- severe systemic disease, (2) secondary angle-closure glaucoma, (3) other ocular diseases, (4) history of intraocular surgery, and (5) unclear examination images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Segment Anatomic Parameters Based on the Scleral Spur and Cornea for Risk Profiling of Primary Angle-closure Glaucoma
The goal of this observational study is to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG). The main question it aims to answer is:
- Are there new anatomical parameters of the anterior segment of the eye that can be used early for risk profiling for PACG? Researchers will compare PACG and narrow angle groups to see if there are some anatomical parameters that can distinguish the two.
Read the detailed description
We aimed to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG).
This retrospective study included 84 patients with PACG and 84 patients with narrow angles (NA). We collected parametric measurements obtained using anterior-segment optical coherence tomography and IOLMaster 700. Univariate and multivariate logistic regression models were used to compare the ocular parameters between the NA and PACG groups as well as to identify risk factors for PACG. The predictive performance of each parameter was evaluated using the area under the receiver operating characteristic curve (AUROC) analysis.
- Conditions
- Glaucoma, Angle-Closure
- 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 |
|---|---|---|
| primary angle-closure glaucoma | Not described | |
| narrow angle | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular scleral-spur angle
The angle between the line of the corneal endothelium 750 μm from the scleral spur to the scleral spur and the bilateral line of the scleral spur
Measured: 2022-11-22 to 2022-12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start22 Nov 2022
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min Ke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Ke, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143943
- Sponsor's protocol ID
- 20231116
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Anatomic Parameters Based on the Scleral Spur and Cornea for Risk Profiling of Primary Angle-closure Glaucoma
- ClinicalTrials.gov ID
- NCT06143943
- Acronym / sponsor ID
- 20231116
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Min KeUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 Nov 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 examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG). The main question it aims to answer is:
- Are there new anatomical parameters of the anterior segment of the eye that can be used early for risk profiling for PACG? Researchers will compare PACG and narrow angle groups to see if there are some anatomical parameters that can distinguish the two.
Detailed description
We aimed to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG).
This retrospective study included 84 patients with PACG and 84 patients with narrow angles (NA). We collected parametric measurements obtained using anterior-segment optical coherence tomography and IOLMaster 700. Univariate and multivariate logistic regression models were used to compare the ocular parameters between the NA and PACG groups as well as to identify risk factors for PACG. The predictive performance of each parameter was evaluated using the area under the receiver operating characteristic curve (AUROC) analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary angle-closure glaucoma | – | – |
| narrow angle | – | – |
Who may qualify
- Ages
- 30 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PACG and anterior chamber angle stenosis were enrolled in this study and excluded from other diseases affecting the structure of the anterior segment of the eye, as well as a history of intraocular surgery.
Key inclusion criteria (2 listed)
- Primary angle-closure glaucoma （PACG) was defined as an occlusion angle with peripheral anterior synechiae and intraocular pressure (IOP) > 21 mmHg or associated with glaucomatous optic neuropathy. The following conditions were identified as possible glaucomatous optic neuropathies, including a vertical cup-to-disc ratio ≥ 0.6, vertical cup-to-disc ratio asymmetry ≥ 0.2, optic disc haemorrhage, and visible retinal nerve fibre layer defect.
- Participants with narrow angle (NA) were selected from among patients with cataracts. NA was defined as a trabecular-iris angle (TIA) < 15° on anterior segment optical coherence tomography, with the exclusion of glaucomatous optic neuropathy or visual field loss.
Key exclusion criteria (1 listed)
- severe systemic disease, (2) secondary angle-closure glaucoma, (3) other ocular diseases, (4) history of intraocular surgery, and (5) unclear examination images.
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
Trabecular scleral-spur angle
Time frame: 2022-11-22 to 2022-12.31
The angle between the line of the corneal endothelium 750 μm from the scleral spur to the scleral spur and the bilateral line of the scleral spur
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 22 Nov 2023.
- 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.
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 Glaucoma, Angle-Closure, run by Min Ke 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 1 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 22 Nov 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?
Trabecular scleral-spur angle (time frame: 2022-11-22 to 2022-12.31). 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 22 Nov 2023.