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

NCT ID: NCT03621579

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-04-01

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.

Conditions

Congenital Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the RNFLT and CMT

the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)

Group Type: OTHER

cataract surgery

Intervention Type: PROCEDURE

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

Interventions

cataract surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• congenital cataract

Exclusion Criteria

• incooperative to complete the preoperative and postoperative examinations

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yune Zhao

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Countries

China

References

Bansal P, Ram J, Sukhija J, Singh R, Gupta A. Retinal Nerve Fiber Layer and Macular Thickness Measurements in Children After Cataract Surgery Compared With Age-Matched Controls. Am J Ophthalmol. 2016 Jun;166:126-132. doi: 10.1016/j.ajo.2016.03.041. Epub 2016 Apr 5.

Reference Type: BACKGROUND

PMID: 27059633 (View on PubMed)

Other Identifiers

RNFL-HZ

Identifier Type: -

Identifier Source: org_study_id