Morbidity of Primary Open Angle GlaucomaMAGICNCT03695224
Matching Glaucoma With Impaired Cognition
An observational study of Morbidity of Primary Open Angle Glaucoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Glaucoma is the leading cause of irreversible blindness in the world. The current study is designed to find the underlying relationship between impairment of topological perception and incidence of glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morbidity of Primary Open Angle Glaucoma
- What is being tested?
- Topological perception test
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 31 Mar 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from communities in Guangzhou and nearby cities. Subjects fulfilling the above eligibility criteria will be enrolled.
Who may be able to join
- Aged between 18-55;
- Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations;
- Spherical equivalent < 3D；
- No history of other ocular diseases (except mild cataract), including diabetic retinopathy, age-related macular degeneration, optical neuropathy, eye trauma, strabismus, nystagmus, severe dry eye, ptosis of the eyelid, etc.
Who cannot join
- Unable or unwilling to sign informed consent, or cannot comply with the study protocol
- Diagnosed with any kind of glaucoma (based on visual field and OCT, etc) or primary angle-closure diseases(primary angle closure suspect and primary angle closure, based on gonioscopy and UBM examination);
- History of ocular surgeries or laser;
- Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening)
- With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc.
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Xiulan Zhang, MD, PhD, zhangxl2@mail.sysu.edu.cn
About this study
Official title: Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study
Glaucoma is the leading cause of irreversible blindness in the world. The current study is designed to find the underlying relationship between impairment of topological perception and incidence of glaucoma.
Read the detailed description
Glaucoma is currently the leading cause of irreversible blindness in the world. It has been a difficult task for ophthalmologists and researchers to diagnose glaucoma, especially in early stage. At present, glaucoma diagnosis mainly relies on OCT and visual field test, which have relatively low sensitivity and specificity at the early stage of glaucoma. Previous studies mainly focused on ocular manifestation of glaucoma. However, there was evidence that abnormalities of visual pathway also existed in patients with glaucoma, indicating cerebral cognitive defects may also be involved in glaucoma development. Thus, the current study was designed, in which subjects at high-risk of developing glaucoma are separated into two group based on test results of topological perception. After five years' follow-up, morbidity of primary open-angle glaucoma would be compared between groups to see if there was any relationship between impaired cognitive function and incidence of glaucoma.
- Conditions
- Morbidity of Primary Open Angle Glaucoma
- Being tested
- Topological perception test
- Keywords
- Topological perception, Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topological perception testDiagnostic test
Participants' topological perception are tested with self-designed devices. Participants are asked to respond to the figures shown on the screen, and a final score will appear after they finish all the questions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects with normal topological perception Receives: Diagnostic Test: Topological perception test | |
| Group B | Subjects with abnormal topological perception Receives: Diagnostic Test: Topological perception test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity of primary open-angle glaucoma
Incidence of primary open angle glaucoma in the study subjects
Measured: From October 2018 to September 2024
Secondary outcomes (2)
Change in biometric parameters of optic nerve and macular region
Biometric parameters of optic nerve include retinal nerve fiber layer (RNFL) thickness, ganglion cell layer (GCL) thickness, ganglion cell complex (GCC) thickness, etc.
Measured: From October 2018 to September 2024
Change in visual field
Mean Deviation (MD value)
Measured: From October 2018 to September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start8 Oct 2018
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidity of Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695224
- Sponsor's protocol ID
- 2018KYPJ126
- Acronym
- MAGIC
- Status last verified
- May 2022
- First submitted
- 2 Oct 2018
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study
- ClinicalTrials.gov ID
- NCT03695224
- Acronym / sponsor ID
- MAGIC / 2018KYPJ126
- Conditions
- Morbidity of Primary Open Angle Glaucoma
- Keywords
- Topological perception, Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Oct 2018 (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 the leading cause of irreversible blindness in the world. The current study is designed to find the underlying relationship between impairment of topological perception and incidence of glaucoma.
Detailed description
Glaucoma is currently the leading cause of irreversible blindness in the world. It has been a difficult task for ophthalmologists and researchers to diagnose glaucoma, especially in early stage. At present, glaucoma diagnosis mainly relies on OCT and visual field test, which have relatively low sensitivity and specificity at the early stage of glaucoma. Previous studies mainly focused on ocular manifestation of glaucoma. However, there was evidence that abnormalities of visual pathway also existed in patients with glaucoma, indicating cerebral cognitive defects may also be involved in glaucoma development. Thus, the current study was designed, in which subjects at high-risk of developing glaucoma are separated into two group based on test results of topological perception. After five years' follow-up, morbidity of primary open-angle glaucoma would be compared between groups to see if there was any relationship between impaired cognitive function and incidence of glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Topological perception testSubjects with normal topological perception |
| Group B | – | Diagnostic Test: Topological perception testSubjects with abnormal topological perception |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from communities in Guangzhou and nearby cities. Subjects fulfilling the above eligibility criteria will be enrolled.
Key inclusion criteria (4 listed)
- Aged between 18-55;
- Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations;
- Spherical equivalent < 3D；
- No history of other ocular diseases (except mild cataract), including diabetic retinopathy, age-related macular degeneration, optical neuropathy, eye trauma, strabismus, nystagmus, severe dry eye, ptosis of the eyelid, etc.
Key exclusion criteria (6 listed)
- Unable or unwilling to sign informed consent, or cannot comply with the study protocol
- Diagnosed with any kind of glaucoma (based on visual field and OCT, etc) or primary angle-closure diseases(primary angle closure suspect and primary angle closure, based on gonioscopy and UBM examination);
- History of ocular surgeries or laser;
- Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening)
- With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topological perception testParticipants' topological perception are tested with self-designed devices. Participants are asked to respond to the figures shown on the screen, and a final score will appear after they finish all the questions. | Diagnostic test | Group A, Group B |
Primary outcome
Morbidity of primary open-angle glaucoma
Time frame: From October 2018 to September 2024
Incidence of primary open angle glaucoma in the study subjects
2 secondary outcomes
Change in biometric parameters of optic nerve and macular region
Time frame: From October 2018 to September 2024
Change in visual field
Time frame: From October 2018 to September 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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.
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 Morbidity of Primary Open Angle Glaucoma, run by 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiulan Zhang (8613570166308, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity of primary open-angle glaucoma (time frame: From October 2018 to September 2024). 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 10 May 2022.