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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03621579
Enrollment
60
Registered
2018-08-08
Start date
2017-03-01
Completion date
2018-04-01
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cataract

Keywords

RNFLT

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.

Interventions

PROCEDUREcataract surgery

To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* congenital cataract

Exclusion criteria

* incooperative to complete the preoperative and postoperative examinations

Design outcomes

Primary

MeasureTime frameDescription
RNFLT1 yearthe retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)
CMT1 yearthe macular thickness (CMT) measured by OCT biometry (Units :um)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026