GlaucomaNCT07580014
Choroidal and Retinal Features in PACD and POAG on OCT and OCTA
An observational study of Glaucoma and OCTA, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Glaucoma is a group of irreversible, progressive optic neuropathies that can lead to severe visual field defects and even blindness, affecting nearly 95 million people worldwide. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to 20 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes an observation cohort of adults diagnosed with POAG or PACD and a control cohort of healthy adults without glaucoma. Eligible participants range in age from 18 to 90 years and have no history of confounding retinal or neurological diseases that would interfere with OCT/OCTA imaging assessment.
Who may be able to join
- Control group: Healthy individuals with no history of ocular surgery, IOP < 21 mmHg, and CDR < 0.5 bilaterally without asymmetry
- Observation group: Glaucoma specialist-confirmed diagnosis of POAG or PACD (per ISGEO staging: PACS/PAC/PACG)
Who cannot join
- History of retinal or macular disease (e.g., AMD, DR, RVO, ERM)
- Non-glaucomatous optic neuropathy (e.g., MS, NMO)
- Poor OCT/OCTA image quality
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yuheng Tan, +02066615461, tanyuhesper@163.com
About this study
Glaucoma is a group of irreversible, progressive optic neuropathies that can lead to severe visual field defects and even blindness, affecting nearly 95 million people worldwide. Based on anterior chamber angle structure, glaucoma is classified into primary angle-closure glaucoma (PACG) and primary open-angle glaucoma (POAG). Although POAG is more common, PACG is more severe and more likely to cause blindness if not managed appropriately. Globally, PACG accounts for approximately 25% of all glaucoma cases but is responsible for roughly 50% of glaucoma-related blindness. Generally, the term "glaucoma" implies optic nerve damage; however, glaucomatous optic neuropathy may be absent in subacute and acute angle-closure glaucoma. Therefore, according to international consensus, primary angle-closure disease is categorized as PACD-encompassing primary angle-closure suspect (PACS), primary angle closure (PAC), and PACG-based on the extent of angle closure, intraocular pressure elevation, and optic nerve damage. With advances in ophthalmic imaging, an increasing array of diagnostic modalities has been applied to glaucoma diagnosis. Optical coherence tomography (OCT), which utilizes low-coherence light to display cross-sectional images of the retina in vivo, represents a rapid, non-invasive, and continuously evolving imaging method. Building upon OCT, OCTA has emerged as a novel imaging technique that allows non-invasive visualization and assessment of blood flow in individual retinal layers [5]. Existing OCT and OCTA research on glaucoma primarily focuses on the optic disc and macula of glaucoma patients, providing evidence of changes in the retinal nerve fiber layer, macular ganglion cell thickness, optic nerve head structure, and peripapillary and macular vasculature. Other studies have examined choroidal vascular architecture and thickness in glaucoma; previous findings from our research group also indicate that choroidal vascular density is significantly lower in eyes with POAG and PACG compared to normal eyes, while choroidal stromal area is significantly greater in PACG than in POAG eyes and normal controls. Further investigation into choroidal and retinal alterations in glaucoma is warranted. Consequently, the OCT and OCTA fundus characteristics of patients with PACD and POAG remain an area with unexplored unknowns. This study utilizes OCT and OCTA to observe the choroidal and retinal tissue structure and vascular hemodynamics in patients with PACD and POAG, aiming to comprehensively investigate structural changes in the glaucomatous fundus, broaden new research directions, and explore and supplement the understanding of glaucoma pathogenesis.
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| Control Group | Inclusion Criteria: 1. Individuals undergoing routine physical examination, generally in good health, with no history of prior surgery. 2. No use of glaucoma medications, no evidence of elevated intraocular pressure (IOP < 21 mmHg), no significant optic nerve head (ONH) asymmetry (cup-to-disc ratio difference < 0.2), and cup-to-disc ratio (CDR) < 0.5 in both eyes. 3. Age between 18 and 90 years, inclusive; any gender. Exclusion Criteria: 1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane). 2. Optic nerve abnormalities other than glaucoma, such as those associated with neurological complications (e.g., Multiple Sclerosis, Neuromyelitis Optica). 3. Poor quality of OCT or OCTA images obtained post-examination. 4. Refusal to sign the informed consent form. | |
| Observation Group | Inclusion Criteria: 1. Confirmed diagnosis of Primary Open-Angle Glaucoma (POAG) or Primary Angle-Closure Disease (PACD) by a glaucoma specialist. The diagnosis of POAG is based on standard clinical criteria, specifically: presence of an open angle, glaucomatous optic neuropathy, current or past elevation of intraocular pressure, and visual field defects [10]. PACD cases are diagnosed and enrolled according to the clinical staging system of PACS, PAC, and PACG as established by the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) . 2. Age between 18 and 90 years, inclusive; any gender. Exclusion Criteria: 1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane). 2. Optic nerve abnormalities other than glaucoma, such as those observed in patients with neurological com |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subfoveal choroidal thickness (μm)
Subfoveal choroidal thickness (SFCT) is defined as the vertical distance between the outer border of the retinal pigment epithelium (RPE)/Bruch's membrane complex and the choroid-scleral junction directly beneath the fovea centralis. This measurement is obtained using a widefield swept-source OCT device, which enables enhanced depth imaging and high-resolution visualization of the choroid.The assessment is subsequently conducted by a masked, experienced grader using the integrated caliper tool. SFCT serves as a quantitative biomarker for choroidal structural changes associated with primary angle-closure disease (PACD) and primary open-angle glaucoma (POAG).
Measured: Day 1
Deviation of the horizontal watershed zone
The deviation of the horizontal watershed zone (HWZ) is assessed by determining whether the HWZ is displaced superiorly or inferiorly relative to the fovea centralis. This evaluation is performed using 24 × 20 mm en face OCTA images acquired with a widefield swept-source OCTA device. All measurements are carried out with the device's built-in caliper tool by a masked, experienced grader. The HWZ deviation serves as a quantitative indicator reflecting alterations in choroidal venous outflow patterns.
Measured: Day 1
Secondary outcomes (1)
Choroidal vascularity index (%)
Choroidal vascularity index (CVI) is defined as the ratio of choroidal vascular volume to total choroidal volume within a designated region, expressed as a percentage, with higher values indicating greater vascular density. The measurement was performed on images acquired with a widefield swept-source OCTA deviceand assessed by a masked, experienced grader.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start16 Jul 2024
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (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.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580014
- Sponsor's protocol ID
- 2024KYPJ067
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal and Retinal Features in PACD and POAG on OCT and OCTA
- ClinicalTrials.gov ID
- NCT07580014
- Acronym / sponsor ID
- 2024KYPJ067
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 12 May 2026 (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.
Glaucoma is a group of irreversible, progressive optic neuropathies that can lead to severe visual field defects and even blindness, affecting nearly 95 million people worldwide. Based on anterior chamber angle structure, glaucoma is classified into primary angle-closure glaucoma (PACG) and primary open-angle glaucoma (POAG). Although POAG is more common, PACG is more severe and more likely to cause blindness if not managed appropriately. Globally, PACG accounts for approximately 25% of all glaucoma cases but is responsible for roughly 50% of glaucoma-related blindness. Generally, the term "glaucoma" implies optic nerve damage; however, glaucomatous optic neuropathy may be absent in subacute and acute angle-closure glaucoma. Therefore, according to international consensus, primary angle-closure disease is categorized as PACD-encompassing primary angle-closure suspect (PACS), primary angle closure (PAC), and PACG-based on the extent of angle closure, intraocular pressure elevation, and optic nerve damage. With advances in ophthalmic imaging, an increasing array of diagnostic modalities has been applied to glaucoma diagnosis. Optical coherence tomography (OCT), which utilizes low-coherence light to display cross-sectional images of the retina in vivo, represents a rapid, non-invasive, and continuously evolving imaging method. Building upon OCT, OCTA has emerged as a novel imaging technique that allows non-invasive visualization and assessment of blood flow in individual retinal layers [5]. Existing OCT and OCTA research on glaucoma primarily focuses on the optic disc and macula of glaucoma patients, providing evidence of changes in the retinal nerve fiber layer, macular ganglion cell thickness, optic nerve head structure, and peripapillary and macular vasculature. Other studies have examined choroidal vascular architecture and thickness in glaucoma; previous findings from our research group also indicate that choroidal vascular density is significantly lower in eyes with POAG and PACG compared to normal eyes, while choroidal stromal area is significantly greater in PACG than in POAG eyes and normal controls. Further investigation into choroidal and retinal alterations in glaucoma is warranted. Consequently, the OCT and OCTA fundus characteristics of patients with PACD and POAG remain an area with unexplored unknowns. This study utilizes OCT and OCTA to observe the choroidal and retinal tissue structure and vascular hemodynamics in patients with PACD and POAG, aiming to comprehensively investigate structural changes in the glaucomatous fundus, broaden new research directions, and explore and supplement the understanding of glaucoma pathogenesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Inclusion Criteria: 1. Individuals undergoing routine physical examination, generally in good health, with no history of prior surgery. 2. No use of glaucoma medications, no evidence of elevated intraocular pressure (IOP < 21 mmHg), no significant optic nerve head (ONH) asymmetry (cup-to-disc ratio difference < 0.2), and cup-to-disc ratio (CDR) < 0.5 in both eyes. 3. Age between 18 and 90 years, inclusive; any gender. Exclusion Criteria: 1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane). 2. Optic nerve abnormalities other than glaucoma, such as those associated with neurological complications (e.g., Multiple Sclerosis, Neuromyelitis Optica). 3. Poor quality of OCT or OCTA images obtained post-examination. 4. Refusal to sign the informed consent form. |
| Observation Group | – | –Inclusion Criteria: 1. Confirmed diagnosis of Primary Open-Angle Glaucoma (POAG) or Primary Angle-Closure Disease (PACD) by a glaucoma specialist. The diagnosis of POAG is based on standard clinical criteria, specifically: presence of an open angle, glaucomatous optic neuropathy, current or past elevation of intraocular pressure, and visual field defects [10]. PACD cases are diagnosed and enrolled according to the clinical staging system of PACS, PAC, and PACG as established by the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) . 2. Age between 18 and 90 years, inclusive; any gender. Exclusion Criteria: 1. Known history of retinal disease, including any condition involving macular degeneration (e.g., age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, viral retinitis, or epiretinal membrane). 2. Optic nerve abnormalities other than glaucoma, such as those observed in patients with neurological com |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes an observation cohort of adults diagnosed with POAG or PACD and a control cohort of healthy adults without glaucoma. Eligible participants range in age from 18 to 90 years and have no history of confounding retinal or neurological diseases that would interfere with OCT/OCTA imaging assessment.
Key inclusion criteria (2 listed)
- Control group: Healthy individuals with no history of ocular surgery, IOP < 21 mmHg, and CDR < 0.5 bilaterally without asymmetry
- Observation group: Glaucoma specialist-confirmed diagnosis of POAG or PACD (per ISGEO staging: PACS/PAC/PACG)
Key exclusion criteria (4 listed)
- History of retinal or macular disease (e.g., AMD, DR, RVO, ERM)
- Non-glaucomatous optic neuropathy (e.g., MS, NMO)
- Poor OCT/OCTA image quality
- Refusal to sign informed consent
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
Subfoveal choroidal thickness (μm)
Time frame: Day 1
Subfoveal choroidal thickness (SFCT) is defined as the vertical distance between the outer border of the retinal pigment epithelium (RPE)/Bruch's membrane complex and the choroid-scleral junction directly beneath the fovea centralis. This measurement is obtained using a widefield swept-source OCT device, which enables enhanced depth imaging and high-resolution visualization of the choroid.The assessment is subsequently conducted by a masked, experienced grader using the integrated caliper tool. SFCT serves as a quantitative biomarker for choroidal structural changes associated with primary angle-closure disease (PACD) and primary open-angle glaucoma (POAG).
Deviation of the horizontal watershed zone
Time frame: Day 1
The deviation of the horizontal watershed zone (HWZ) is assessed by determining whether the HWZ is displaced superiorly or inferiorly relative to the fovea centralis. This evaluation is performed using 24 × 20 mm en face OCTA images acquired with a widefield swept-source OCTA device. All measurements are carried out with the device's built-in caliper tool by a masked, experienced grader. The HWZ deviation serves as a quantitative indicator reflecting alterations in choroidal venous outflow patterns.
1 secondary outcome
Choroidal vascularity index (%)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
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 and OCTA, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuheng Tan (+02066615461, tanyuhesper@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subfoveal choroidal thickness (μm) (time frame: Day 1). 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 12 May 2026.