Effects of Visual Reconstruction on Brain Function and Structure in Children With Congenital Cataract

September 1, 2022 updated by: Haotian Lin, Sun Yat-sen University
Children have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. With the continuous improvement of surgical approaches and surgical techniques, the success rate of congenital cataract surgery has been significantly improved clinically, and the visual function of children has been significantly improved after surgery. However, to date, there has been no experimental study of specific changes in the brain before and after surgery in children with congenital cataracts to explore its relationship with visual reconstruction. We aim to investigate the effects of congenital cataract surgery on the brain function and structure of children through preoperative and postoperative analysis and comparison of brain imaging such as BOLD-fMRI and DTI, and provide new ideas for the clinical treatment and prognostic assessment of this disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • SunYat-senU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with congenital cataracts

Description

Inclusion Criteria:

  • Children with congenital cataracts

Exclusion Criteria:

  • Other oculo-cerebral and systemic diseases that may affect the outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Congenital cataracts children (0~3 years)
Children with congenital cataracts between the ages of 0 and 3 years
Device: MRI
Brain testing of patients using MRI
Normal children (0~3 years)
Children without congenital cataracts between the ages of 0 and 3 years
Device: MRI
Brain testing of patients using MRI
Congenital cataracts children (6~18 years)
Children with congenital cataracts between the ages of 6 and 18 years
Device: MRI
Brain testing of patients using MRI
Normal children (6~18 years)
Children without congenital cataracts between the ages of 6 and 18 years
Device: MRI
Brain testing of patients using MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from functional magnetic resonance imaging
Time Frame: 1 week before surgery , 1 month, 3 month, 6 month after surgery
1 week before surgery , 1 month, 3 month, 6 month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from best corrected visual acuity
Time Frame: 1 week before surgery , 1 month, 3 month, 6 month after surgery
1 week before surgery , 1 month, 3 month, 6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Haotian Lin, study principal investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (ACTUAL)

September 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019KYPJ055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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