NCT04427748

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 9, 2020

Last Update Submit

June 9, 2020

Conditions

Congenital Cataract

Keywords

ERG

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

congenital cataract group

children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG

age-matched normal children group

age-matched normal children are perfomed ERG

Eligibility Criteria

Age18 Months - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least 1 year

You may qualify if:

  • 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

You may not qualify if:

  • patients with mild cataracts do not require surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hosptial of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

  • Wang J, Wang Y, Guan W, Zhao YE. Full-field electroretinogram recorded with skin electrodes in 6- to 12-year-old children. Doc Ophthalmol. 2023 Dec;147(3):179-188. doi: 10.1007/s10633-023-09944-9. Epub 2023 Aug 2.

    PMID: 37530953DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

January 1, 2018

Primary Completion

September 12, 2019

Study Completion

December 3, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

CN(1)