NCT04120818

Brief Summary

In this prospective study , a cohort of 58 eyes with congenital cataract from Wenzhou medical university was erolled.33 eyes with congenital cataract was after lensectomy and anterior vitrectomy as post-surger group, 26 eyes without cataract surgery as control group. The cytokines of MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15 was evaluated

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 4, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

June 19, 2019

Last Update Submit

October 6, 2019

Conditions

Congenital Cataract

Keywords

inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

  • inflammatory cytokines

    investigate inflammatory microenvironment changes in the aqueous of children after surgery.aqueous humor levels of cytokines, chemokines and growth factors including TGFβ2, TNF-α, IL-6, IP10, IL-10, MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15.

    before the surgery of secondary IOL implantation

Study Arms (2)

SIOL group

aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation

Procedure: secondary IOL implantation

PIOL group

children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Procedure: primary IOL implantation

Interventions

secondary IOL implantationPROCEDURE

reopened the fibrotic, closed capsular bag and achieve IOL placement

SIOL group
primary IOL implantationPROCEDURE

lensectomy and anterior vitrectomy and primary IOL implantation

PIOL group

Eligibility Criteria

Age10 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

congenital cataract age from 10 months to 72 months who underwent cataract surgery or aphakic children age from 15 months to 72 months who underwent secondary IOL implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eye Hosptial of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

Study Design

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

Study Record Dates

First Submitted

June 19, 2019

First Posted

October 9, 2019

Study Start

March 4, 2016

Primary Completion

February 12, 2017

Study Completion

February 12, 2017

Last Updated

October 9, 2019

Record last verified: 2019-09

Locations

CN(2)