Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy

Completed

• Conditions: Congenital Cataract
• Interventions: Procedure: primary IOL implantation; Procedure: secondary IOL implantation

• Registration Number: NCT04120818
• Lead Sponsor: yin ying zhao

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

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 Timeline

• Study Start: 2016-03-04
• Primary Completion: 2017-02-12
• Study Completion: 2017-02-12
• Study First Submitted: 2019-06-19
• Status Verified: 2019-09
• Study First Submitted QC: 2019-10-06
• Last Update Submitted: 2019-10-06
• Study First Posted: 2019-10-09
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PIOL group	primary IOL implantation	children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation
SIOL group	secondary IOL implantation	aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation

Primary Outcome Measures

Name	Time	Method
inflammatory cytokines	before the surgery of secondary IOL implantation	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.

Trial Locations

Locations (2)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China

Eye Hosptial of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China