NCT02151318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 21, 2014

Last Update Submit

June 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cultured TM cell toxicity caused by new glaucoma medications

    6 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having glaucoma and undergoing a trabeculotomy

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hosipital

Tampa, Florida, 33606, United States

Location

Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

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.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Chad A Dickey, PhD

    University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute

    PRINCIPAL INVESTIGATOR
  • Carla Bourne, MD

    University of South Florida and Tampa General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 30, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2016

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations