Quantitative Assessment of the Retina Using Optical Coherence Tomography (OCT) and Fundus and Associations With Brain Function
Associations Between Retina and Brain Function
Sponsors
Source
Sun Yat-sen University
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
Case-control studies and meta-analysis have reported that several fundus features, especially
the thickness of the peripapillary retinal nerve fiber layer, are related to the brain
degeneration and cognitive impairment. In our study, we aim to quantitatively assess retina
features using OCT and define its associations with brain development and intelligence in
children.
Overall Status
Recruiting
Start Date
2019-12-25
Completion Date
2020-04-30
Primary Completion Date
2020-03-30
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
macular thickness |
recorded at enrollment |
|
score of Wechsler intelligence scale |
recorded at enrollment |
|
the visual information processing function |
recorded at enrollment |
Secondary Outcome
Measure |
Time Frame |
|
refractive status |
recorded at enrollment |
|
intraocular pressure |
recorded at enrollment |
|
fundus picture |
recorded at enrollment |
Enrollment
200
Condition
Eligibility
Study Pop
Healthy children aged 3 to 12 years old. Patients who have been diagnosed with ocular
diseases (physiological myopia excluded) and nervous system diseases were excluded.
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- age from 3 to 12 years old
Exclusion Criteria:
- diagnosed with ocular diseases before (physiological myopia excluded) diagnosed with
nervous system disease before
Gender
All
Minimum Age
3 Years
Maximum Age
12 Years
Overall Contact
Last Name
Yifan Xiang, M.D
Phone
18826234461
565098660@qq.com
Location
Facility |
Status |
Contact |
Investigator |
|
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong 510060 China |
Recruiting |
Last Name: Haotian Lin, Ph.D Phone: +86-020-87330274 Email: gddlht@aliyun.com |
Last Name: Haotian Lin, Ph.D Role: Principal Investigator |
Location Countries
Country
China
Verification Date
2020-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Sun Yat-sen University
Investigator Full Name
Haotian Lin
Investigator Title
Clinical Professor
Has Expanded Access
No
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Haotian Lin, M.D,Ph.D
Phone
13802793086
haot.lin@hotmail.com
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Other
Time Perspective
Cross-Sectional
Study First Submitted
December 30, 2019
Study First Submitted Qc
January 10, 2020
Study First Posted
January 13, 2020
Last Update Submitted
January 10, 2020
Last Update Submitted Qc
January 10, 2020
Last Update Posted
January 13, 2020
ClinicalTrials.gov processed this data on January 15, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.