- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626847
How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?
November 17, 2016 updated by: George L. Spaeth MD, Wills Eye
Nuclear Genetic and Mitochondrial Influences in Glaucoma
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 Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
97
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Glaucoma Service
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
glaucoma clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
Primary Open Angle Glaucoma (POAG)
|
2
Controls (Normals, patients without glaucoma)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one blood draw
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Epub 2012 Apr 21.
- 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. Epub 2012 Jun 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
February 20, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (Estimate)
February 29, 2008
Study Record Updates
Last Update Posted (Estimate)
November 21, 2016
Last Update Submitted That Met QC Criteria
November 17, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#07-826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Two manuscripts have been written and published.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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