The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma
Primary Purpose
Glaucoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collection of trabecular meshwork tissue during surgery
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma focused on measuring Mitochondria, trabeculectomy, trabecular meshwork, Glaucoma surgery
Eligibility Criteria
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
Sites / Locations
- Wills Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glaucoma subjects
Control cadaver eyes
Arm Description
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.
control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University
Outcomes
Primary Outcome Measures
3-D EM tomography for mitochondria obtained from sample tissue
Secondary Outcome Measures
Gene expression of Drp1
Full Information
NCT ID
NCT02524431
First Posted
August 6, 2015
Last Updated
November 18, 2016
Sponsor
Wills Eye
Collaborators
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02524431
Brief Title
The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma
Official Title
The Changes of Mitochondrial Dynamics and the Molecular Mechanisms in the Trabecular Meshwork of Patients With Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain mitochondrial samples
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Mitochondria, trabeculectomy, trabecular meshwork, Glaucoma surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control cadaver eyes
Arm Type
Active Comparator
Arm Description
control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University
Intervention Type
Other
Intervention Name(s)
Collection of trabecular meshwork tissue during surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-D EM tomography for mitochondria obtained from sample tissue
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Gene expression of Drp1
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Spaeth, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma
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