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Clinical Trials/NCT03621579
NCT03621579
Completed
Not Applicable

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

Wenzhou Medical University2 sites in 1 country60 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Cataract
Sponsor
Wenzhou Medical University
Enrollment
60
Locations
2
Primary Endpoint
CMT
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
April 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yune Zhao

director

Wenzhou Medical University

Eligibility Criteria

Inclusion Criteria

  • congenital cataract

Exclusion Criteria

  • incooperative to complete the preoperative and postoperative examinations

Outcomes

Primary Outcomes

CMT

Time Frame: 1 year

the macular thickness (CMT) measured by OCT biometry (Units :um)

RNFLT

Time Frame: 1 year

the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)

Study Sites (2)

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