Electrophysiology in Congenital Cataract After Lensectomy and Anterior

Congenital Cataract Clinical Trial

Official title:

The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427748
• Other study ID #: Electrophysiology-WJJ
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 3, 2019

Study information

• Verified date: June 2020
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.

Description:

Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).

electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 3, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 15 Years

Eligibility

Inclusion Criteria:

• phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Exclusion Criteria:

• patients with mild cataracts do not require surgery

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Locations

Country	Name	City	State
China	Eye Hosptial of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ERG	investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.	at least 1year after the surgery of congenital cataract