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Clinical Trials/NCT03695224
NCT03695224
Recruiting
Not Applicable

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

Sun Yat-sen University1 site in 1 country3,000 target enrollmentOctober 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbidity of Primary Open Angle Glaucoma
Sponsor
Sun Yat-sen University
Enrollment
3000
Locations
1
Primary Endpoint
Morbidity of primary open-angle glaucoma
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 8, 2018
End Date
March 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Xiulan Zhang

Director of Clinical Research Center

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Aged between 18-55;
  • Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations;
  • Spherical equivalent \< 3D;
  • 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

  • Unable or unwilling to sign informed consent, or cannot comply with the study protocol
  • 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);
  • History of ocular surgeries or laser;
  • Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening)
  • With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc.
  • Pregnancy or lactation

Outcomes

Primary Outcomes

Morbidity of primary open-angle glaucoma

Time Frame: From October 2018 to September 2024

Incidence of primary open angle glaucoma in the study subjects

Secondary Outcomes

  • Change in biometric parameters of optic nerve and macular region(From October 2018 to September 2024)
  • Change in visual field(From October 2018 to September 2024)

Study Sites (1)

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