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Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136473
First Posted: June 3, 2010
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center
  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 Orna Geyer, Carmel Medical Center:

Primary Outcome Measures:
  • cell culture [ Time Frame: one year ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
congenital cataract or aphakic glaucoma
children with 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Aqueous from the anterior chamber will be withdrawn before surgery.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

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136473


Locations
Israel
Carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Orna Geyer, Prof Carmel Medical Center
  More Information

Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01136473     History of Changes
Other Study ID Numbers: CMC-10-0035-CTIL
First Submitted: May 27, 2010
First Posted: June 3, 2010
Last Update Posted: February 24, 2015
Last Verified: February 2015

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

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