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Matching Glaucoma With Impaired Cognition (MAGIC)

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ClinicalTrials.gov Identifier: NCT03695224
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Xiulan Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment
Morbidity of Primary Open Angle Glaucoma Diagnostic Test: Topological perception test

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Group A
Subjects with normal topological perception
Diagnostic Test: Topological perception 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.

Group B
Subjects with abnormal topological perception
Diagnostic Test: Topological perception 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.




Primary Outcome Measures :
  1. Morbidity of primary open-angle glaucoma [ Time Frame: From October 2018 to September 2024 ]

Secondary Outcome Measures :
  1. Change in biometric parameters of optic nerve and macular region [ Time Frame: From October 2018 to September 2024 ]
    Biometric parameters of optic nerve include retinal nerve fiber layer (RNFL) thickness, ganglion cell layer (GCL) thickness, ganglion cell complex (GCC) thickness, etc.

  2. Change in visual field [ Time Frame: From October 2018 to September 2024 ]
    Mean Deviation (MD value)


Biospecimen Retention:   Samples With DNA
10 ml of whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from communities in Guangzhou and nearby cities. Subjects fulfilling the above eligibility criteria will be enrolled.
Criteria

Inclusion Criteria:

  1. Aged between 18-55;
  2. Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations;
  3. Spherical equivalent < 3D;
  4. 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.

Exclusion Criteria:

  1. Unable or unwilling to sign informed consent, or cannot comply with the study protocol
  2. 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);
  3. History of ocular surgeries or laser;
  4. Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening)
  5. With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc.
  6. Pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695224


Contacts
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Contact: Xiulan Zhang 8613570166308 zhangxl2@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xiulan Zhang, MD, PhD       zhangxl2@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Chinese Academy of Sciences

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Responsible Party: Xiulan Zhang, Director of Clinical Research Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03695224     History of Changes
Other Study ID Numbers: 2018KYPJ126
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiulan Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University:
Topological perception
Glaucoma

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases