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

This study has been completed.
DataMed Devices Inc.
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc. Identifier:
First received: January 5, 2011
Last updated: June 24, 2013
Last verified: June 2013
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

Resource links provided by NLM:

Further study details as provided by Carl Zeiss Meditec, Inc.:

Primary Outcome Measures:
  • To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters. [ Time Frame: Study was released before December 1, 2012 ]

Enrollment: 119
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
subjects with glaucoma

Detailed Description:

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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:


  • 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.


  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01272102

United States, California
Stanford Eye Institute
Palo Alto, California, United States, 94303
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
United States, Utah
Utah Eye Institute
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
DataMed Devices Inc.
Principal Investigator: Donald Budenz, MD Bascom Palmer Eye Institute
Principal Investigator: Robert Chang, MD Stanford Eye Institute
Principal Investigator: Arvind Neelakantan, MD Glaucoma Associates of Texas
Principal Investigator: Alan Crandall, MD Utah Eye Institute
  More Information

Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61

Responsible Party: Carl Zeiss Meditec, Inc. Identifier: NCT01272102     History of Changes
Other Study ID Numbers: HD-OCT-GCA-2010-1
Study First Received: January 5, 2011
Last Updated: June 24, 2013

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on May 23, 2017