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

Recruiting

• Conditions: Congenital Cataracts
• Interventions: Device: MRI

• Registration Number: NCT05527925
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children with congenital cataracts

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal children (0~3 years)	MRI	Children without congenital cataracts between the ages of 0 and 3 years
Normal children (6~18 years)	MRI	Children without congenital cataracts between the ages of 6 and 18 years
Congenital cataracts children (0~3 years)	MRI	Children with congenital cataracts between the ages of 0 and 3 years
Congenital cataracts children (6~18 years)	MRI	Children with congenital cataracts between the ages of 6 and 18 years

Primary Outcome Measures

Name	Time	Method
Change from functional magnetic resonance imaging	1 week before surgery , 1 month, 3 month, 6 month after surgery

Secondary Outcome Measures

Name	Time	Method
Change from best corrected visual acuity	1 week before surgery , 1 month, 3 month, 6 month after surgery

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China