ClinicalTrials.Veeva

Menu

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

W

Wenzhou Medical University

Status

Completed

Conditions

Congenital Cataract

Treatments

Procedure: cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03621579
RNFL-HZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

1 month to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • congenital cataract

Exclusion criteria

  • incooperative to complete the preoperative and postoperative examinations

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

the RNFLT and CMT
Other group
Description:
the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)
Treatment:
Procedure: cataract surgery

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems