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

NCT05527925 | Unknown

• 1 other identifier: 2019KYPJ055
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Cataracts

Outcome Measures

Primary Outcomes (1)

• Change from functional magnetic resonance imaging

  1 week before surgery , 1 month, 3 month, 6 month after surgery

Secondary Outcomes (1)

• Change from best corrected visual acuity

  1 week before surgery , 1 month, 3 month, 6 month after surgery

Study Arms (4)

Congenital cataracts children (0~3 years)

Children with congenital cataracts between the ages of 0 and 3 years

Device: MRI

Normal children (0~3 years)

Children without congenital cataracts between the ages of 0 and 3 years

Device: MRI

Congenital cataracts children (6~18 years)

Children with congenital cataracts between the ages of 6 and 18 years

Device: MRI

Normal children (6~18 years)

Children without congenital cataracts between the ages of 6 and 18 years

Device: MRI

Interventions

MRI DEVICE

Brain testing of patients using MRI

Congenital cataracts children (0~3 years); Congenital cataracts children (6~18 years); Normal children (0~3 years); Normal children (6~18 years)

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with congenital cataracts

You may qualify if:

• Children with congenital cataracts

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

• Haotian Lin

  Study Principal Investigator

  STUDY DIRECTOR

Central Study Contacts

Wei Xiao

CONTACT

13535160850; 969834781@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: April 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

CN (1)