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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120818
Other study ID # yyzhao
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 4, 2016
Est. completion date February 12, 2017

Study information

Verified date September 2019
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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) and videos were collected to review the capsular reconstruction condition and lens implantation position.

Aqueous humor (100-200 μl) was aspirated from each patient before the surgery. The research was to evaluate the relationship between the cytokine profile in aqueous humor and the state of capsule after Lensectomy and Anterior Vitrectomy.Aqueous humor was obtained , Human Magnetic Luminex Screening Assay was used to determine the aqueous humor levels of cytokines.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date February 12, 2017
Est. primary completion date February 12, 2017
Accepts healthy volunteers No
Gender All
Age group 10 Months to 72 Months
Eligibility Inclusion Criteria: aphakic 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

-

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
secondary IOL implantation
reopened the fibrotic, closed capsular bag and achieve IOL placement
primary IOL implantation
lensectomy and anterior vitrectomy and primary IOL implantation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
yin ying zhao

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary inflammatory cytokines investigate inflammatory microenvironment changes in the aqueous of children after surgery.aqueous humor levels of cytokines, chemokines and growth factors including TGFß2, TNF-a, IL-6, IP10, IL-10, MCP-1, VEGF, IL-1, IFN-?, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15. before the surgery of secondary IOL implantation
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