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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02524431
• Other study ID #: 14-430E
• Status: Withdrawn
• Phase: N/A
• First received: August 6, 2015
• Last updated: November 18, 2016
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-D EM tomography for mitochondria obtained from sample tissue		1 year	No
Secondary	Gene expression of Drp1		1 year	No