NCT02524431

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

August 6, 2015

Last Update Submit

November 18, 2016

Conditions

Glaucoma

Keywords

Mitochondriatrabeculectomytrabecular meshworkGlaucoma surgery

Outcome Measures

Primary Outcomes (1)

  • 3-D EM tomography for mitochondria obtained from sample tissue

    1 year

Secondary Outcomes (1)

  • Gene expression of Drp1

    1 year

Study Arms (2)

Glaucoma subjects

ACTIVE COMPARATOR

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

Control cadaver eyes

ACTIVE COMPARATOR

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

Interventions

Collection of trabecular meshwork tissue during surgeryOTHER

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 eyesGlaucoma subjects

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • George Spaeth, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 14, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

US(1)