Expired Study
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Philadelphia, Pennsylvania 19107


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.


Study summary:

Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) 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. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.


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


Study is Available At:


Original ID:

IRB#07-826


NCT ID:

NCT00626847


Secondary ID:


Study Acronym:


Brief Title:

How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?


Official Title:

Nuclear Genetic and Mitochondrial Influences in Glaucoma


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wills Eye


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

97


Enrollment Type:

Actual


Overall Contact Information

Official Name:George L Spaeth, MD
Principal Investigator
Wills Eye Institute

Study Dates

Start Date:March 2008
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 17, 2016
First Received Date:February 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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:one blood draw
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Primary Open Angle Glaucoma (POAG)
Study Arm Type:Other
Arm Name:2
Description:Controls (Normals, patients without glaucoma)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wills Eye
Agency Class:Other
Agency Type:Collaborator
Agency Name:Jefferson Medical College of Thomas Jefferson University

Samples and Retentions

Sample Retention:Samples With DNA
Description: whole blood
Study Population: glaucoma clinic
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation:Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Unaltered myocilin expression in the blood of primary open angle glaucoma patients. Mol Vis. 2012;18:1004-9.
PMID:22550394
Reference Type:Results Reference
Citation:Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Absence of altered expression of optineurin in primary open angle glaucoma patients. Mol Vis. 2012;18:1421-7.
PMID:22690120

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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