Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy

Expression Profile of Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy

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

Study Overview

• Status: Completed
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: secondary IOL implantation; Procedure: primary IOL implantation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Ophthalmology and Optometry Hospital
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hosptial of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIOL group; aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation	Procedure: secondary IOL implantation; reopened the fibrotic, closed capsular bag and achieve IOL placement
PIOL group; children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation	Procedure: primary IOL implantation; lensectomy and anterior vitrectomy and primary IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: yin ying zhao

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2016
• Primary Completion (ACTUAL): February 12, 2017
• Study Completion (ACTUAL): February 12, 2017

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: inflammatory cytokines
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: yyzhao

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No