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Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma


N/A
40 Years
N/A
Not Enrolling
Both
Glaucoma

Thank you

Trial Information

Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma


To determine the area under the Receiver Operator Characteristic Curve (AUC) for the
following GCA parameters:

1. Minimum thickness

2. Supero-temporal thickness

3. Superior thickness

4. Supero-nasal thickness

5. Infero-temporal thickness

6. Inferior thickness

7. Infero-nasal thickness


Inclusion Criteria:



- Age of 40 years or older

- Diagnosed to have glaucoma by the Principal Investigator or co-investigator

- Able and willing to make the required study visits

- Able and willing to give consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

- Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on
a Snellen equivalent acuity chart.

- Refractive error outside -12.00D to +8.00D spherical range or >-3.00D cylinder.

- Previous vitreoretinal surgery in study eye.

- Vitreoretinal traction or epiretinal membrane in the study eye.

- Any active infection of anterior or posterior segments.

- Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal
disease in the study eye upon dilated examination, or upon evaluation of retinal
photos.

Systemic:

- History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or
multiple sclerosis.

- A life threatening or debilitating disease.

- Participation in any study involving a non-FDA approved investigational drug (IND)
within the past month, or ongoing participation in a study with a non-FDA approved or
cleared investigational device (IDE).

- Current or recent (within the past 14 days) use of an agent with photosensitizing
properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline,
etc.).

- Concomitant use of hydrochloroquine and/or chloroquine.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.

Outcome Time Frame:

Study was released before December 1, 2012

Safety Issue:

No

Principal Investigator

Donald Budenz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bascom Palmer Eye Institute

Authority:

United States: Institutional Review Board

Study ID:

HD-OCT-GCA-2010-1

NCT ID:

NCT01272102

Start Date:

November 2010

Completion Date:

March 2011

Related Keywords:

  • Glaucoma
  • Ganglion Cysts
  • Glaucoma

Name

Location

Stanford Eye Institute Palo Alto, California  94303
Bascom Palmer Eye Institute Miami, Florida  33136
Glaucoma Associates of Texas Dallas, Texas  75231
Utah Eye Institute Salt Lake City, Utah  84107