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

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621579
• Other study ID #: RNFL-HZ
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: August 2018
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

Inclusion Criteria:

• congenital cataract

Exclusion Criteria:

• incooperative to complete the preoperative and postoperative examinations

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

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

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNFLT	the retinal nerve fiber layer thickness (RNFLT)measured by OCT biometry (Units :um)	1 year
Primary	CMT	the macular thickness (CMT) measured by OCT biometry (Units :um)	1 year