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How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?
This study is currently recruiting participants.
Verified by Wills Eye, November 2008
Sponsored by: Wills Eye
Information provided by: Wills Eye
ClinicalTrials.gov Identifier: NCT00626847
  Purpose

Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.


Condition Intervention
Primary Open Angle Glaucoma
Primary Angle Closure Glaucoma
Pseudoexfoliation Glaucoma
Genetic: Nuclear Genetic and Mitochondrial DNA

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Nuclear Genetic and Mitochondrial Influences in Glaucoma

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • The investigators will sequence the entire mitochondrial genome to determine mitochondrial DNA nucleotide changes associated with different types of glaucoma in ethnic Americans. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood


Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Primary Open Angle Glaucoma (POAG)
Genetic: Nuclear Genetic and Mitochondrial DNA
Mapping of your genetic make-up
2
Primary Angle Closure Glaucoma (PACG)
Genetic: Nuclear Genetic and Mitochondrial DNA
Mapping of your genetic make-up
3
Pseudoexfoliation Glaucoma
Genetic: Nuclear Genetic and Mitochondrial DNA
Mapping of your genetic make-up
4
Controls (Normals)
Genetic: Nuclear Genetic and Mitochondrial DNA
Mapping of your genetic make-up

Detailed Description:

Four tubes of blood will be taken from 600 people. Of those, half will have glaucoma and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. Three groups will consist of POAG, PACG, and Pseudoexfoliation glaucoma. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

glaucoma clinic

Criteria

Inclusion Criteria:

  • 40 yrs
  • Caucasian or African American
  • Male or female with POAG, PACG, PXFG,
  • Normal

Exclusion Criteria:

  • Other ophthamic co-morbidities
  • Other ethnic groups
  • Unable to understand and give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626847

Contacts
Contact: George L Spaeth, MD 215-928-3197 gspaeth@willseye.org
Contact: Jeanne L Molineaux, COA 215-825-4713 jmolineaux@willseye.org

Locations
United States, Pennsylvania
Wills Eye Glaucoma Service Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mary Jo Schwartz     215-928-3123     mschwartz@willseye.org    
Contact: Sheryl S Wizov, COA     215-928-3221     swizov@willseye.org    
Sub-Investigator: Jonathan S Myers, MD            
Sub-Investigator: Jay L Katz, MD            
Sub-Investigator: Marlene R Moster, MD            
Sub-Investigator: Michael J Pro, MD            
Sub-Investigator: Courtland M Schmidt, MD            
Sub-Investigator: Scott Fudemberg, MD            
Sub-Investigator: Arun Prasad, MD            
Sub-Investigator: Anand Montravadi, MD            
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: George L Spaeth, MD Wills Eye Institute
  More Information

Responsible Party: Wills Eye Institute ( George L. Spaeth, MD )
Study ID Numbers: IRB#07-826
Study First Received: February 20, 2008
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00626847  
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
primary open angle glaucoma
primary angle closure glaucoma
pseudoexfoliation glaucoma
Nuclear Genetics
Mitochondrial DNA
POAG
PACG
PXFG

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Exfoliation Syndrome
Glaucoma, Angle-Closure
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Uveal Diseases
Iris Diseases

ClinicalTrials.gov processed this record on January 16, 2009