Clinical trial NCT03695224: Matching Glaucoma With Impaired Cognition
Official title: Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidity of Primary Open Angle Glaucoma
Keywords: Topological perception
Glaucoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2018-10-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from communities in Guangzhou and nearby cities. Subjects fulfilling the above eligibility criteria will be enrolled.

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.

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

Primary outcomes:
measure: Morbidity of primary open-angle glaucoma
timeFrame: From October 2018 to September 2024
Secondary outcomes:
measure: Change in biometric parameters of optic nerve and macular region
timeFrame: From October 2018 to September 2024
measure: Change in visual field
timeFrame: From October 2018 to September 2024
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References: