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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03621579

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Procedure: cataract surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: the RNFLT and CMT the retinal nerve fiber layer (RNFLT) and macular thickness (CMT)	Procedure: cataract surgery To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery

Arm

Intervention/Treatment

Other: the RNFLT and CMT

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

Procedure: cataract surgery

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

congenital cataract

Exclusion Criteria:

incooperative to complete the preoperative and postoperative examinations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China	325027
2	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yune Zhao, director, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT03621579

Other Study ID Numbers:

RNFL-HZ

First Posted:

Aug 8, 2018

Last Update Posted:

Aug 8, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yune Zhao, director, Wenzhou Medical University

RNFLT

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 8, 2018