Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy

Sponsor

yin ying zhao (Other)

Overall Status

Completed

CT.gov ID

NCT04120818

Collaborator

(none)

Enrollment

Locations

11.3

Actual Duration (Months)

29.5

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	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 Design

Study Type:

Observational

Actual Enrollment :

59 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 4, 2016

Actual Primary Completion Date :

Feb 12, 2017

Actual Study Completion Date :

Feb 12, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Months to 72 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hosptial of Wenzhou Medical College	Wenzhou	Zhejiang	China	325027
2	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

yin ying zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yin ying zhao, Clinical professor, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT04120818

Other Study ID Numbers:

yyzhao

First Posted:

Oct 9, 2019

Last Update Posted:

Oct 9, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by yin ying zhao, Clinical professor, Wenzhou Medical University

inflammatory cytokines

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Oct 9, 2019