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

NCT ID: NCT02524431

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Keywords

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Mitochondria trabeculectomy trabecular meshwork Glaucoma surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Collection of trabecular meshwork tissue during surgery

Intervention Type OTHER

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.

Control cadaver eyes

control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University

Group Type ACTIVE_COMPARATOR

Collection of trabecular meshwork tissue during surgery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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George L. Spaeth MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Spaeth, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Locations

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Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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14-430E

Identifier Type: -

Identifier Source: org_study_id