Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

June 24, 2024 updated by: University of South Florida
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

12

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

    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hosipital
      • Tampa, Florida, United States, 33613
        • Byrd Alzheimer's Institute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients having glaucoma and undergoing a trabeculotomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

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 (Actual)

December 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimated)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 15309

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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