Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery

Not Applicable

Completed

• Conditions: Congenital Cataract
• Interventions: Procedure: cataract surgery

• Registration Number: NCT03621579
• Lead Sponsor: Wenzhou Medical University

Brief Summary

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the retinal nerve fiber layer. However, there are different opinions about the effect of amblyopia on the optic nerve fiber thickness around the optic disc at home and abroad. Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before and after surgery. Investigators dynamically observed changes in RNFL and CMT to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

Detailed Description

This prospective study reviewed children with CC who were undergoing cataract extraction with IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. bilateral and unilateral CC children were placed in Study group, while age-matched normal children were included as controls. Children who were uncooperative to complete the preoperative and postoperative examinations were excluded.

All eyes were divided into 4 groups. Group 1: form deprivation amblyopia of unilateral CC, Group 2: unaffected eyes of unilateral CC, Group 3: form deprivation amblyopia of bilateral CC, Group 4: normal eyes of normal children. The preoperative and postoperative data including sex, age at surgery, 7 position of RNFLT and CMT were collected.

All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Investigators used OCT biometry to measure participants' the retinal nerve fiber layer (RNFLT) and macular thickness (CMT) before surgery and 1 week, 1 month, 3 months, and 6 months and 1 year after surgery, and compared with age-matched normal children.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-04-01
• Study First Submitted: 2018-04-10
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• congenital cataract

Exclusion Criteria

• incooperative to complete the preoperative and postoperative examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the RNFLT and CMT	cataract surgery	the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)

Primary Outcome Measures

Name	Time	Method
CMT	1 year	the macular thickness (CMT) measured by OCT biometry (Units :um)
RNFLT	1 year	the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)

Trial Locations

Locations (2)

Eye Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China