Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01136473
First received: May 27, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition
Congenital Cataract
Aphakic or Pseudophakic Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
congenital cataract or aphakic glaucoma

Detailed 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Aqueous from the anterior chamber will be withdrawn before surgery.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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children 0-18

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136473

Contacts
Contact: Orna Geyer, Prof 04-8250419 orna_geyer@clalit.org.il

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Orna Geyer, Professor    97248250419    orna_geyer@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Orna Geyer, Prof Carmel Medical Center
  More Information

No publications provided

Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01136473     History of Changes
Other Study ID Numbers: CMC-10-0035-CTIL
Study First Received: May 27, 2010
Last Updated: October 10, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
congenital cataract
aphakic
pseudophakic glaucoma
pediatric patients

Additional relevant MeSH terms:
Cataract
Glaucoma
Lens Diseases
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on August 21, 2014