Matching Glaucoma With Impaired Cognition

NCT ID: NCT03695224

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2025-03-31

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.

Conditions

Morbidity of Primary Open Angle Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Subjects with normal topological perception

Topological perception test

Intervention Type: DIAGNOSTIC_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

Topological perception test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiulan Zhang

Director of Clinical Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiulan Zhang

Role: CONTACT

zhangxl2@mail.sysu.edu.cn

8613570166308

Facility Contacts

Xiulan Zhang, MD, PhD

Role: primary

zhangxl2@mail.sysu.edu.cn

Other Identifiers

2018KYPJ126

Identifier Type: -

Identifier Source: org_study_id