Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients

Congenital Cataract Clinical Trial

Official title:

Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients: Exploring the Pathophysiology Through Lens Epithelial Cell Culture and Isolation of Candidate Factors From Aqueous Humor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136473
• Other study ID #: CMC-10-0035-CTIL
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: February 22, 2015
• Start date: July 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.

Description:

Aqueous from the anterior chamber will be withdrawn before surgery. Then the lens capsule will be opened (capsulorhexis) and removed. The lens material will be removed. All 3 components will be sent to the lab.

Lens epithelial cells will be isolated and will be used in a co-culture setup with trabecular cells to investigate the interactions between lens cells and trabecular cells. Understanding the interaction between young and adult lens cells on trabecular cell will shed light on mechanism of infantile aphakic glaucoma.

Aqueous humor taken out before cataract surgery and before glaucoma operation of aphakic eyes will be used for analysis of growth factor and cytokines in the Aphakic eye using proteins membrane arrays. Eyes before cataract surgery will be used as controls. Such analysis will shed light on the possible factors affecting trabecular cells in aphakic eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• children with congenital cataract and are going to do removal surgery

• children with aphakic or pseudophakic glaucoma and are going to do glaucoma surgery

• both of parents are able to sign the INFORMED CONSENT FORM

Exclusion Criteria:

• patients with other eye diseases apart from congenital cataract(in children with congenital cataract) and aphakic or pseudophakic glaucoma (in children with aphakic or pseudophakic glaucoma)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Aphakic or Pseudophakic Glaucoma
• Cataract
• Congenital Cataract
• Glaucoma

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cell culture	In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.	one year	No