Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

Glaucoma Clinical Trial

Official title:

Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02151318
• Other study ID #: 15309
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2014
• Last updated: June 25, 2015
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: June 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having glaucoma and undergoing a trabeculotomy

• Sign ICF (Informed Consent Form)

Exclusion Criteria:

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Locations

Country	Name	City	State
United States	Byrd Alzheimer's Institute	Tampa	Florida
United States	Tampa General Hosipital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma.	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	No
Secondary	Cultured TM cell toxicity caused by new glaucoma medications	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	No