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

Not Applicable

Withdrawn

• Conditions: Glaucoma
• Interventions: Other: Collection of trabecular meshwork tissue during surgery

• Registration Number: NCT02524431
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glaucoma subjects	Collection of trabecular meshwork tissue during surgery	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 eyes	Collection of trabecular meshwork tissue during surgery	control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University

Primary Outcome Measures

Name	Time	Method
3-D EM tomography for mitochondria obtained from sample tissue	1 year

Secondary Outcome Measures

Name	Time	Method
Gene expression of Drp1	1 year

Trial Locations

Locations (1)

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States