Matching Glaucoma With Impaired Cognition

Sponsor:

Collaborators:

Information provided by (Responsible Party):

xiulan zhang，Zhongshan Ophthalmic Center, Sun Yat-sen University

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 8, 2018

Estimated Primary Completion Date

September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Morbidity of primary open-angle glaucoma[ Time Frame: From October 2018 to September 2024 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in optic nerve structure, visual field, etc. (eg. RNFL thickness, mean deviation, etc.)[ Time Frame: From October 2018 to September 2024 ]

Descriptive Information

Brief Title ^ICMJE

Matching Glaucoma With Impaired Cognition

Official Title ^ICMJE

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

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, we design a cohort study, 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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

: Group A
Subjects with normal topological perception
: Group B
Subjects with abnormal topological perception

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 31, 2025

Estimated Primary Completion Date

September 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

xiulan zhang，Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Zhongshan Ophthalmic Center, Sun Yat-sen University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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