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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. Identifier: NCT04226729
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT04226729

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Contact: Yifan Xiang, M.D 18826234461
Contact: Haotian Lin, M.D,Ph.D 13802793086

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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   
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 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