Matching Glaucoma With Impaired Cognition

Recruiting

• Conditions: Morbidity of Primary Open Angle Glaucoma
• Interventions: Diagnostic Test: Topological perception test

• Registration Number: NCT03695224
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2018-10-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-10
• Primary Completion: 2024-09-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Topological perception test	Subjects with abnormal topological perception
Group A	Topological perception test	Subjects with normal topological perception

Primary Outcome Measures

Name	Time	Method
Morbidity of primary open-angle glaucoma	From October 2018 to September 2024	Incidence of primary open angle glaucoma in the study subjects

Secondary Outcome Measures

Name	Time	Method
Change in biometric parameters of optic nerve and macular region	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.
Change in visual field	From October 2018 to September 2024	Mean Deviation (MD value)

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China