The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma

November 18, 2016 updated by: George L. Spaeth MD, Wills Eye

The Changes of Mitochondrial Dynamics and the Molecular Mechanisms in the Trabecular Meshwork of Patients With Glaucoma

The purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

During a routine trabeculectomy surgery, a corneo-scleral block that includes TM tissue will be collected at the operating room. This tissue is routinely removed during every trabeculectomy surgery. The tissue will be stored immediately in normal saline at 4 degrees Celsius, and walked directly to the Jefferson Center for Translational Medicine at Thomas Jefferson University by the Wills eye glaucoma research fellow. TM tissue will be identified using light microscope base on TM cell pigmentation. The ocular tissue will be fixed and placed in pre-cooled fixative on ice for 1 hour. The lengths of mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.

Study Type

Interventional

Phase

  • Not Applicable

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital

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

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum 2-year diagnosis of POAG
  • Moderate to advanced stage of the disease
  • DDLS stages 5 through 10 with visual field loss
  • Age between 21 and 80 years
  • Planned trabeculectomy with or without concomitant cataract surgery

Exclusion Criteria:

  • Age ≤ 20 years old
  • Any other type of glaucoma other than POAG
  • Patients who had undergone selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
  • Patients with history of ocular trauma
  • Patients with previous eye surgery will be excluded both from the study and the control groups

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Glaucoma subjects
During glaucoma surgery, collection of trabecular meshwork tissue during surgery that is not needed is cut away from the surgical site. The physician will keep this tissue for analysis by the researchers at Wills Eye Hospital and Thomas Jefferson University Center for Translational Medicine.
Other: Collection of trabecular meshwork tissue during surgery
Tissue is collected during surgery at Wills Eye and then processed at thomas jefferson to identify the trabecular meshwork using light microscope. The ocular tissue will be fixed and the mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.
ACTIVE_COMPARATOR: Control cadaver eyes
control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University
Other: Collection of trabecular meshwork tissue during surgery
Tissue is collected during surgery at Wills Eye and then processed at thomas jefferson to identify the trabecular meshwork using light microscope. The ocular tissue will be fixed and the mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-D EM tomography for mitochondria obtained from sample tissue
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Gene expression of Drp1
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Wills Eye

Collaborators

Thomas Jefferson University

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

November 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-430E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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