Matching Glaucoma With Impaired Cognition

Morbidity of Primary Open Angle Glaucoma Clinical Trial

— MAGIC  

Official title:

Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695224
• Other study ID #: 2018KYPJ126
• Status: Recruiting
• Start date: October 8, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Xiulan Zhang
• Phone: 8613570166308
• Email: zhangxl2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Morbidity of Primary Open Angle Glaucoma

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity of primary open-angle glaucoma	Incidence of primary open angle glaucoma in the study subjects	From October 2018 to September 2024
Secondary	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
Secondary	Change in visual field	Mean Deviation (MD value)	From October 2018 to September 2024