Matching Glaucoma With Impaired Cognition (MAGIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Morbidity of Primary Open Angle Glaucoma
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Xiulan Zhang; Phone Number: 8613570166308; Email: zhangxl2@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Xiulan Zhang, MD, PhD; Email: zhangxl2@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity of primary open-angle glaucoma	Incidence of primary open angle glaucoma in the study subjects	From October 2018 to September 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From October 2018 to September 2024
Change in visual field	Mean Deviation (MD value)	From October 2018 to September 2024

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Glaucoma; Topological perception
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2018KYPJ126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No