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Associations Between Retina and Brain Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226729
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

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.

Condition or disease
Healthy

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Quantitative Assessment of the Retina Using Optical Coherence Tomography (OCT) and Fundus and Associations With Brain Function
Actual Study Start Date : December 25, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : April 30, 2020



Primary Outcome Measures :
  1. macular thickness [ Time Frame: recorded at enrollment ]
    collected with fundus optical coherence tomography

  2. score of Wechsler intelligence scale [ Time Frame: recorded at enrollment ]
    the normal scores ranged form 90-109

  3. the visual information processing function [ Time Frame: recorded at enrollment ]
    collected with the electroencephalogram


Secondary Outcome Measures :
  1. refractive status [ Time Frame: recorded at enrollment ]
    the refractive status of both eyes

  2. intraocular pressure [ Time Frame: recorded at enrollment ]
    the intraocular pressure of both eyes

  3. fundus picture [ Time Frame: recorded at enrollment ]
    the fundus pictures of both eyes



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226729


Contacts
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Contact: Yifan Xiang, M.D 18826234461 565098660@qq.com
Contact: Haotian Lin, M.D,Ph.D 13802793086 haot.lin@hotmail.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Haotian Lin, Ph.D    +86-020-87330274    gddlht@aliyun.com   
Principal Investigator: Haotian Lin, Ph.D         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04226729    
Other Study ID Numbers: VISION201901
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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