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Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

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. Identifier: NCT02151318
Recruitment Status : Unknown
Verified June 2015 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : May 30, 2014
Last Update Posted : June 26, 2015
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment. This tissue would normally be discarded. These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Official Title: Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
Study Start Date : December 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Primary Outcome Measures :
  1. Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma. [ Time Frame: 6 weeks ]
    TM cell biopsy samples from patients with glaucoma will be harvested and cultured in a laboratory setting to grow primary human TM cells. These cells will be used to test different medications, looking at the medications ability to reduce cellular pathologies commonly seen in TM tissue of patients with glaucoma. Pathologies include myocilin aggregation, and cell death. This will help researchers to determine the most effective compounds in treating glaucoma.

Secondary Outcome Measures :
  1. Cultured TM cell toxicity caused by new glaucoma medications [ Time Frame: 6 weeks ]
    Cultured primary TM cells treated with various new medications synthesized to treat cellular pathologies associated with glaucoma, will also be analyzed to look at toxicity caused by the treatments themselves. THis will help to determine the safety of these new medications prior to being administered to patients.

Biospecimen Retention:   Samples Without DNA
The ophthalmologist will collect samples from the tissue that is removed during patients eye surgery that would otherwise be discarded or thrown away. Researchers will collect the sample and grow in the laboratory conditions. These cells will then be studied for further research on glaucoma.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having glaucoma and undergoing a trabeculotomy

Inclusion Criteria:

  • Patients having glaucoma and undergoing a trabeculotomy
  • Sign ICF (Informed Consent Form)

Exclusion Criteria:

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 identifier (NCT number): NCT02151318

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United States, Florida
Tampa General Hosipital Recruiting
Tampa, Florida, United States, 33606
Contact: Carla Bourne, MD    813-974-5853   
Principal Investigator: Carla Bourne, MD         
Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Chad A Dickey, PhD    813-396-0639   
Principal Investigator: Chad A Dickey, PhD         
Sub-Investigator: Andrew R Stothert, MS         
Sponsors and Collaborators
University of South Florida
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Principal Investigator: Chad A Dickey, PhD University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute
Study Director: Carla Bourne, MD University of South Florida and Tampa General Hospital

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Responsible Party: University of South Florida Identifier: NCT02151318     History of Changes
Other Study ID Numbers: 15309
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases